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Improving Retreatment Success (IMPRESS) (IMPRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02114684
Recruitment Status : Completed
First Posted : April 15, 2014
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Nesri Padayatchi, Centre for the AIDS Programme of Research in South Africa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Recurrent Tuberculosis
Intervention Drug: moxifloxacin
Enrollment 197
Recruitment Details  
Pre-assignment Details One individual in the control arm was terminated one month after enrollment owing to discovery of pre-existing violation of entry criteria. The individual was excluded from all statistical analyses.
Arm/Group Title Moxifloxacin Control
Hide Arm/Group Description

A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.

The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.

Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38–54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38–54 and ≥55 kg, respectively.

An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.

Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).

During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 – 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 – 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid.

Period Title: Overall Study
Started 98 98
Completed 86 88
Not Completed 12 10
Reason Not Completed
Death             6             4
Lost to Follow-up             1             2
Withdrawal by Subject             1             2
Relocation             3             1
Rifampicin resistant on culture             0             1
Patient Incarcerated             1             0
Arm/Group Title Moxifloxacin Control Total
Hide Arm/Group Description

A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.

The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.

Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38–54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38–54 and ≥55 kg, respectively.

An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.

Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).

During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 – 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 – 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid.

Total of all reporting groups
Overall Number of Baseline Participants 98 98 196
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 98 participants 196 participants
<25 years
7
   7.1%
14
  14.3%
21
  10.7%
=>25 and <35 years
37
  37.8%
35
  35.7%
72
  36.7%
=>35 and <=45 years
35
  35.7%
32
  32.7%
67
  34.2%
>45 years
19
  19.4%
17
  17.3%
36
  18.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 98 participants 196 participants
Female
24
  24.5%
35
  35.7%
59
  30.1%
Male
74
  75.5%
63
  64.3%
137
  69.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 98 participants 196 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
96
  98.0%
98
 100.0%
194
  99.0%
White
1
   1.0%
0
   0.0%
1
   0.5%
More than one race
1
   1.0%
0
   0.0%
1
   0.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
South Africa Number Analyzed 98 participants 98 participants 196 participants
98
 100.0%
98
 100.0%
196
 100.0%
1.Primary Outcome
Title Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation
Hide Description The proportion of patients with negative sputum cultures at the end of the intensive phase (8 weeks) and the proportion of patients with negative sputum cultures at 6 months were compared between the two study arms. All participants with sputum culture results at week 8 and month 6 were included in the analysis.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Nine participants had missing data at week 8: 4 missed visits, 3 terminated before week 8 and 2 had MOTT cultured. Fourteen had missing data at month 6: 7 were terminated before month 6 and 7 missed their visits.
Arm/Group Title Moxifloxacin Control
Hide Arm/Group Description:

A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.

The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.

Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38–54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38–54 and ≥55 kg, respectively.

An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.

Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).

During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 – 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 – 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid.

Overall Number of Participants Analyzed 98 98
Measure Type: Count of Participants
Unit of Measure: Participants
culture negative at 8 weeks Number Analyzed 94 participants 93 participants
78
  83.0%
73
  78.5%
culture negative at 6 months Number Analyzed 88 participants 94 participants
84
  95.5%
92
  97.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Control
Comments comparison of culture negative results at week 8
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Control
Comments comparison of culture negative results at month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Time to Culture-conversion of the Moxifloxacin Regimen and the Ethambutol Regimen
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Moxifloxacin Control
Hide Arm/Group Description:

A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.

The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.

Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38–54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38–54 and ≥55 kg, respectively.

An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.

Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).

During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 – 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 – 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid.

Overall Number of Participants Analyzed 98 98
Median (Inter-Quartile Range)
Unit of Measure: weeks
6.0
(4.0 to 8.3)
7.9
(4.0 to 11.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Gehan-Breslow-Wilcoxon test
Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms
Hide Description To compare the proportion of patients with any Grade 3 or 4 adverse reactions in the two study arms. Outcome measured in terms of number of participants with at least one grade 3 or 4 events, and not in number of events.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Moxifloxacin Control
Hide Arm/Group Description:

A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.

The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.

Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38–54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38–54 and ≥55 kg, respectively.

An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.

Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).

During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 – 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 – 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid.

Overall Number of Participants Analyzed 98 98
Measure Type: Count of Participants
Unit of Measure: Participants
43
  43.9%
25
  25.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Number of Participants With Adverse Events and 8-week Culture Conversion Rates Among HIV-infected Patients vs. HIV-uninfected Patients
Hide Description To compare adverse events and 8-week culture conversion rates among HIV-infected patients vs. HIV-uninfected patients. The proportion of participants with at least one grade 3 or 4 adverse event was measured.
Time Frame up to 2 years for adverse events and 8 weeks for culture conversion rates
Hide Outcome Measure Data
Hide Analysis Population Description
9 participants had missing data at 8 weeks: 4 missed visits, 3 terminated before week 8, and 2 had MOTT cultured
Arm/Group Title HIV Positive, Moxifloxacin HIV Positive, Control HIV Negative, Moxifloxacin HIV Negative, Control
Hide Arm/Group Description:
HIV negative participants based on HIV status at study enrollment, who were assigned to the Moxifloxacin group
HIV positive participants based on HIV status at study enrollment, who were assigned to the control group
HIV negative participants based on HIV status at study enrollment, who were assigned to the Moxifloxacin arm
HIV negative participants based on HIV status at study enrollment, who were assigned to the control group
Overall Number of Participants Analyzed 70 68 28 30
Measure Type: Count of Participants
Unit of Measure: Participants
participants with grade 3/4 adverse events Number Analyzed 70 participants 68 participants 28 participants 30 participants
30
  42.9%
19
  27.9%
13
  46.4%
6
  20.0%
participants culture negative at 8 weeks Number Analyzed 67 participants 64 participants 27 participants 29 participants
57
  85.1%
51
  79.7%
21
  77.8%
22
  75.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Positive, Moxifloxacin, HIV Positive, Control, HIV Negative, Moxifloxacin, HIV Negative, Control
Comments Comparison of the number of adverse events in the two arms, controlling for HIV status
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments There are significantly more adverse events in the active arm
Method Mantel Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HIV Positive, Moxifloxacin, HIV Positive, Control, HIV Negative, Moxifloxacin, HIV Negative, Control
Comments Comparison of the 8-week culture conversion rates in the two arms, controlling for HIV status
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Proportion of Patients With Unfavourable Outcomes or Tuberculosis Recurrence in the Moxifloxacin and Control Arm.
Hide Description A patient was defined as having an unfavourable outcome if he/she was not cured at the end of treatment or did not successfully complete treatment. Recurrence after completion of treatment was defined as two positive cultures within a period of four months without an intervening negative culture.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Moxifloxacin Control
Hide Arm/Group Description:

A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.

The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.

Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38–54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38–54 and ≥55 kg, respectively.

An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.

Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).

During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 – 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 – 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid.

Overall Number of Participants Analyzed 98 98
Measure Type: Count of Participants
Unit of Measure: Participants
13
  13.3%
6
   6.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Moxifloxacin Control
Hide Arm/Group Description

A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol.

The intervention arm substituted moxifloxacin for ethambutol (moxifloxacin group), and consisted of daily doses of moxifloxacin, rifampicin, isoniazid and pyrazinamide for 8 weeks, followed by daily doses of moxifloxacin, rifampicin and isoniazid for 16 weeks.

Participants in the moxifloxacin arm received daily 400 mg of moxifloxacin (Avelox®, Bayer Healthcare), weight-based rifampicin at 450 or 600 mg, and 225 or 300 mg of isoniazid, for participants 38–54 and ≥55 kg, respectively, during the 2-month intensive phase and 4-month continuation phase of TB treatment. During the intensive phase of treatment, pyrazinamide was used at 1500 and 2000mg in participants between 38–54 and ≥55 kg, respectively.

An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), substituting Ethambutol for Moxifloxacin.

Daily doses of rifampicin, isoniazid, pyrazinamide and ethambutol for 8 weeks (intensive phase), followed by daily doses of rifampicin and isoniazid for 16 weeks (Continuation phase).

During the first two months (intensive phase) of treatment, participants in the control arm received the following weight-based doses by fixed dose combination tablets: Participants who were 38 – 54kg received rifampicin 450mg, isoniazid 225mg, pyrazinamide 1200mg, ethambutol 825mg; participants who were 54 – 70kg received rifampicin 600mg, isoniazid 300mg, pyrazinamide 1600mg, ethambutol 1100mg; participants who were > 70 kg received rifampicin 750mg, isoniazid 375mg, pyrazinamide 2000mg, ethambutol 1375mg. During the subsequent four months (continuation phase), participants continued on the same weight-based doses of rifampicin and isoniazid.

All-Cause Mortality
Moxifloxacin Control
Affected / at Risk (%) Affected / at Risk (%)
Total   6/98 (6.12%)      4/98 (4.08%)    
Hide Serious Adverse Events
Moxifloxacin Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/98 (27.55%)      12/98 (12.24%)    
Blood and lymphatic system disorders     
Anaemia * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Thrombocytopenia * 1  1/98 (1.02%)  1 1/98 (1.02%)  1
Lymphadenopathy * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Neutropenia * 1  1/98 (1.02%)  2 0/98 (0.00%)  0
Eye disorders     
Visual acuity reduced * 1  0/98 (0.00%)  0 4/98 (4.08%)  4
Gastrointestinal disorders     
Pancreatitis acute * 1  2/98 (2.04%)  2 0/98 (0.00%)  0
Haemorrhoids * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
General disorders     
Injection site paraesthesia * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Death * 1  3/98 (3.06%)  3 3/98 (3.06%)  3
Non-cardiac chest pain * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Treatment failure * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Hepatobiliary disorders     
Hepatitis * 1  2/98 (2.04%)  2 0/98 (0.00%)  0
Infections and infestations     
Nosocomial infection * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Cellulitis * 1  1/98 (1.02%)  1 1/98 (1.02%)  1
Gastroenteritis * 1  1/98 (1.02%)  1 1/98 (1.02%)  1
Abscess * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Bronchopneumonia * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Lower respiratory tract infection * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Lung abscess * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Pneumonia * 1  1/98 (1.02%)  1 1/98 (1.02%)  1
Scrotal abscess * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Sepsis * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Wound sepsis * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Disseminated tuberculosis * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Pulmonary tuberculosis * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Tuberculosis * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Hepatitis B * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Herpes zoster * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Epidemic vomiting syndrome * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Injury, poisoning and procedural complications     
Head injury * 1  2/98 (2.04%)  2 0/98 (0.00%)  0
Investigations     
Platelet count decreased * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Alanine aminotransferase increased * 1  1/98 (1.02%)  1 1/98 (1.02%)  1
Aspartate aminotransferase increased * 1  2/98 (2.04%)  2 1/98 (1.02%)  1
Neurological examination abnormal * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Weight decreased * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Creatinine renal clearance decreased * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Blood osmolarity decreased * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Hypercalcaemia * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle spasms * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Nervous system disorders     
Optic neuritis * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Trigeminal neuralgia * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Psychiatric disorders     
Confusional state * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Acute psychosis * 1  1/98 (1.02%)  1 1/98 (1.02%)  1
Psychotic disorder * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Renal and urinary disorders     
Renal impairment * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchiectasis * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Emphysema * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Acute respiratory distress syndrome * 1  2/98 (2.04%)  2 0/98 (0.00%)  0
Pleural effusion * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Dyspnoea * 1  4/98 (4.08%)  4 0/98 (0.00%)  0
Haemoptysis * 1  1/98 (1.02%)  2 1/98 (1.02%)  1
Respiratory failure * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Surgical and medical procedures     
Bach's flower remedy * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Vascular disorders     
Deep vein thrombosis * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
1
Term from vocabulary, MedDRA2
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Moxifloxacin Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/98 (30.61%)      19/98 (19.39%)    
Blood and lymphatic system disorders     
Anaemia * 1  2/98 (2.04%)  2 1/98 (1.02%)  1
Normochromic normocytic anaemia * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Thrombocytopenia * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Febrile neutropenia * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Neutropenia * 1  6/98 (6.12%)  7 2/98 (2.04%)  2
Endocrine disorders     
Inappropriate antidiuretic hormone secretion * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Eye disorders     
Visual acuity reduced * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Gastrointestinal disorders     
Diarrhoea * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Nausea * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
General disorders     
Fatigue * 1  1/98 (1.02%)  1 1/98 (1.02%)  1
Chest pain * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Acute hepatic failure * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Infections and infestations     
Pneumonia * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Sputum purulent * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Bone tuberculosis * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Disseminated tuberculosis * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Extrapulmonary tuberculosis * 1  2/98 (2.04%)  2 0/98 (0.00%)  0
Tuberculosis * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Hepatitis B * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Investigations     
Amylase increased * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Alanine aminotransferase increased * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Aspartate aminotransferase increased * 1  4/98 (4.08%)  4 0/98 (0.00%)  0
Blood bilirubin increased * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Weight decreased * 1  5/98 (5.10%)  5 2/98 (2.04%)  2
Blood creatinine increased * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Creatinine renal clearance decreased * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite * 1  2/98 (2.04%)  3 2/98 (2.04%)  2
Hyponatraemia * 1  1/98 (1.02%)  1 1/98 (1.02%)  1
Hyperglycaemia * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Hyperamylasaemia * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Hypoalbuminaemia * 1  4/98 (4.08%)  4 1/98 (1.02%)  1
Gout * 1  1/98 (1.02%)  1 1/98 (1.02%)  1
Hyperuricaemia * 1  2/98 (2.04%)  2 2/98 (2.04%)  2
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Female reproductive tract carcinoma in situ * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Nervous system disorders     
Ataxia * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Psychiatric disorders     
Suicidal ideation * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Renal and urinary disorders     
Haematuria * 1  1/98 (1.02%)  1 2/98 (2.04%)  3
Reproductive system and breast disorders     
Gynaecomastia * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Skin and subcutaneous tissue disorders     
Dermatitis allergic * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Rash generalised * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
Vascular disorders     
Hypotension * 1  1/98 (1.02%)  1 0/98 (0.00%)  0
Hypertension * 1  0/98 (0.00%)  0 1/98 (1.02%)  1
1
Term from vocabulary, MedDRA2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mrs Nonhlanhla Yende-Zuma
Organization: CAPRISA
Phone: 0027312604392
EMail: Nonhlanhla.Yende@caprisa.org
Layout table for additonal information
Responsible Party: Dr Nesri Padayatchi, Centre for the AIDS Programme of Research in South Africa
ClinicalTrials.gov Identifier: NCT02114684    
Other Study ID Numbers: CAP 011
First Submitted: January 29, 2014
First Posted: April 15, 2014
Results First Submitted: February 27, 2019
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019