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Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia

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ClinicalTrials.gov Identifier: NCT02605122
Recruitment Status : Terminated (Development not proceeding)
First Posted : November 16, 2015
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Community-acquired Bacterial Pneumonia
Interventions Drug: Solithromycin
Drug: Standard of Care
Enrollment 97
Recruitment Details Subjects who met all inclusion/exclusion criteria and sign the informed consent/assent were enrolled. Subjects were randomized to receive solithromycin or a comparator antibiotic, administered IV and/or by mouth (PO) based on weight and age. Subjects received safety and efficacy assessments during and after treatment.
Pre-assignment Details  
Arm/Group Title Solithromycin Standard of Care
Hide Arm/Group Description Solithromycin was dosed for 5-7 days. Orally, as capsules or as a suspension, or intravenously. Subjects could receive intravenous therapy initially and switch to an oral formulation. Comparators were dosed according to age and were consistent with current recommendations for treatment of CABP in children per site standard of care.
Period Title: Overall Study
Started 73 24
Received Study Drug 70 24
Completed 68 22
Not Completed 5 2
Reason Not Completed
Withdrawal by Subject             4             1
Lost to Follow-up             1             1
Arm/Group Title Solithromycin Standard of Care Total
Hide Arm/Group Description Solithromycin was dosed for 5-7 days. Comparators were does up to 10 days per site standard of care. Total of all reporting groups
Overall Number of Baseline Participants 70 24 94
Hide Baseline Analysis Population Description
All subjects who receive at least one dose of study drug (solithromycin or active comparator) were included in the analysis population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 24 participants 94 participants
<=18 years
70
 100.0%
24
 100.0%
94
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 24 participants 94 participants
9.48  (4.71) 9.65  (4.95) 9.57  (4.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 24 participants 94 participants
Female
30
  42.9%
11
  45.8%
41
  43.6%
Male
40
  57.1%
13
  54.2%
53
  56.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 24 participants 94 participants
Hispanic or Latino
2
   2.9%
2
   8.3%
4
   4.3%
Not Hispanic or Latino
65
  92.9%
21
  87.5%
86
  91.5%
Unknown or Not Reported
3
   4.3%
1
   4.2%
4
   4.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 24 participants 94 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
12
  17.1%
4
  16.7%
16
  17.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  15.7%
2
   8.3%
13
  13.8%
White
47
  67.1%
16
  66.7%
63
  67.0%
More than one race
0
   0.0%
1
   4.2%
1
   1.1%
Unknown or Not Reported
0
   0.0%
1
   4.2%
1
   1.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 24 participants 94 participants
Hungary 19 4 23
United States 18 9 27
Philippines 12 4 16
Bulgaria 21 6 27
Spain 0 1 1
1.Primary Outcome
Title Overview of Adverse Events By Treatment Arm
Hide Description Summary of subjects experiencing Treatment Emergent Adverse Events (TEAE) through Day 16 visit and Treatment Emergent Serious Adverse Events (TESAE) through Day 28 visit (28 days +/- 4 days after randomization)
Time Frame Up to 28 days post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment through Day 28 (28 days +/- 4days after randomization)
Arm/Group Title Solithromycin Standard of Care
Hide Arm/Group Description:
Solithromycin was dosed for 5-7 days.
Comparators were dosed up to 10 days per site standard of care.
Overall Number of Participants Analyzed 70 24
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE
24
  34.3%
7
  29.2%
TESAE
1
   1.4%
1
   4.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solithromycin, Standard of Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.
Method Clopper-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion experiencing TEAE or TESAE
Estimated Value 34.3
Confidence Interval (2-Sided) 95%
23 to 47
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Summary of Early Clinical Response
Hide Description Early clinical response (ECR) was defined using the latest efficacy evaluation from Day 2 (if subject discharged prior to Day 2), Day3, or Day 4, and was defined as improvement in at least 1 presenting sign/symptom of CABP with no deterioration in any signs/symptoms of CABP and no requirement for an additional antibiotic.
Time Frame During Treatment Days 3 to 4
Hide Outcome Measure Data
Hide Analysis Population Description
Not all subjects had the Early Clinical Improvement assessment performed.
Arm/Group Title Solithromycin Standard of Care
Hide Arm/Group Description:
Solithromycin was dosed for 5-7 days.
Comparators were dosed up to 10 days per site standard of care.
Overall Number of Participants Analyzed 51 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66.7
(52 to 79)
46.7
(21 to 73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solithromycin, Standard of Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.
Method Clopper-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Achievement of ECR
Estimated Value 62.1
Confidence Interval (2-Sided) 95%
49 to 74
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Summary of Clinical Improvement
Hide Description Clinical improvement was assessed using the latest efficacy evaluation conducted on last day of treatment (+48 hours), and was defined identically to the early clinical response.
Time Frame Last day of Treatment (+48 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Not all subjects had the Clinical Improvement assessment performed.
Arm/Group Title Solithromycin Standard of Care
Hide Arm/Group Description:
Solithromycin was dosed for 5-7 days.
Comparators were dosed up to 10 days per site standard of care.
Overall Number of Participants Analyzed 62 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
64.5
(51 to 76)
81
(58 to 95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solithromycin, Standard of Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.
Method Clopper-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Achievement of Clinical Improvement
Estimated Value 68.7
Confidence Interval (2-Sided) 95%
58 to 78
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Summary of Clinical Cure
Hide Description Clinical cure was assessed using the latest efficacy evaluation conducted on Day 16 (+/- 4 days) post-randomization, and was defined as resolution of all presenting signs/symptoms of CABP (excluding cough), no development of new signs/symptoms of CABP, and no requirement for an additional antibiotic.
Time Frame Short-term follow-up at 16 days (+/- 4 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Not all subjects had the Clinical cure assessment performed.
Arm/Group Title Solithromycin Standard of Care
Hide Arm/Group Description:
Solithromycin was dosed for 5-7 days.
Comparators were dosed up to 10 days per site standard of care.
Overall Number of Participants Analyzed 60 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60.0
(47 to 72)
68.4
(43 to 87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Solithromycin, Standard of Care
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No p-value was performed. Study prematurely discontinued. Clopper-Pearson was used to determine confidence intervals.
Method Clopper-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Achievement of Clinical Cure
Estimated Value 62
Confidence Interval (2-Sided) 95%
50 to 73
Estimation Comments [Not Specified]
Time Frame Up to 32 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Solithromycin Standard of Care
Hide Arm/Group Description Solithromycin was dosed for 5-7 days. Comparators were dosed up to 10 days per sites standard of care.
All-Cause Mortality
Solithromycin Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Solithromycin Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/70 (1.43%)      1/24 (4.17%)    
Infections and infestations     
Pneumonia  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Pneumonia Viral  1  0/70 (0.00%)  0 1/24 (4.17%)  1
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Solithromycin Standard of Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/70 (34.29%)      7/24 (29.17%)    
Blood and lymphatic system disorders     
Anaemia  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Cardiac disorders     
Bradycardia  1  0/70 (0.00%)  0 1/24 (4.17%)  1
Gastrointestinal disorders     
Diarrhoea  1  1/70 (1.43%)  1 4/24 (16.67%)  4
Abdominal Discomfort  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Vomiting  1  1/70 (1.43%)  1 0/24 (0.00%)  0
General disorders     
Fatigue  1  0/70 (0.00%)  0 1/24 (4.17%)  1
Infusion Site Pain  1  6/70 (8.57%)  6 0/24 (0.00%)  0
Infusion Site Pruritus  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Infusion Site Urticaria  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Injection Site Reaction  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Oedema Peripheral  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Infections and infestations     
Bacteraemia  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Infectious Pleural Effusion  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Investigations     
Alanine Aminotransferase Increased  1  3/70 (4.29%)  3 0/24 (0.00%)  0
Hepatic Enzyme Increased  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Oxygen Saturation Decreased  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Transaminases Increased  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalaemia  1  0/70 (0.00%)  0 1/24 (4.17%)  1
Hyperglycaemia  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nasal Congestion  1  0/70 (0.00%)  0 1/24 (4.17%)  1
Epistaxis  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Rhinitis Allergic  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Tachypnoea  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Rash  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Rash Erythematous  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Rash Maculo-Papular  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Urticaria  1  1/70 (1.43%)  1 0/24 (0.00%)  0
Vascular disorders     
Phlebitis  1  5/70 (7.14%)  5 0/24 (0.00%)  0
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
The study was discontinued early due to a company business decision. Study discontinuation was not related to safety or tolerability.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Study Site will not submit its results for independent publication until after a coordinated, multicenter Study publication has been submitted or one (1) year after the conclusion of the Study, whichever occurs first. Study Site and/or Investigator shall submit any proposed publication or presentation resulting from Study Site’s performance of the Protocol to the Prime Recipient for review and comment at least forty-five (45) days prior to the date of submission.
Results Point of Contact
Name/Title: Melissa Allaband
Organization: Cempra Pharmeuticals, a wholly owned subsidary of Melinta Therapeutics, Inc.
Phone: 9199140822
Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02605122     History of Changes
Other Study ID Numbers: CE01-203
First Submitted: November 10, 2015
First Posted: November 16, 2015
Results First Submitted: November 6, 2018
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019