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Anaemetro I.V. Infusion 500mg Drug Use Investigation

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ClinicalTrials.gov Identifier: NCT03491228
Recruitment Status : Completed
First Posted : April 9, 2018
Results First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Conditions Anaerobic Infection
Infectious Enterocolitis
Amebic Dysentery
Enrollment 107
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ANAEMETRO Intravenous Infusion (Metronidazole)
Hide Arm/Group Description Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician’s discretion.
Period Title: Overall Study
Started 107
Completed 107
Not Completed 0
Arm/Group Title ANAEMETRO Intravenous Infusion (Metronidazole)
Hide Arm/Group Description Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician’s discretion.
Overall Number of Baseline Participants 107
Hide Baseline Analysis Population Description
A total of 107 participants were enrolled in this study. There was no participant excluded from the baseline analysis.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
<15 years Number Analyzed 107 participants
0
≥15 and <65 years Number Analyzed 107 participants
40
≥65 years Number Analyzed 107 participants
67
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 107 participants
69
Female Number Analyzed 107 participants
38
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Target Diseases   [1] 
Measure Type: Number
Unit of measure:  Participants
Anaerobic infection Number Analyzed 107 participants
74
Infectious enterocolitis Number Analyzed 107 participants
23
Amebic dysentery Number Analyzed 107 participants
7
Infectious enterocolitis + amebic dysentery Number Analyzed 107 participants
3
[1]
Measure Description: Target diseases for this study were anaerobic infection, infectious enterocolitis, amebic dysentery, and the infection with both infectious enterocolitis and amebic dysentery.
1.Primary Outcome
Title Number of Participants With Adverse Drug Reaction (ADR)
Hide Description An adverse drug reaction (ADR) was any untoward medical occurrence attributed to ANAEMETRO Intravenous infusion in a participant who received ANAEMETRO Intravenous infusion. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to ANAEMETRO Intravenous infusion was assessed by the physician.
Time Frame Maximum 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set comprised of participants who satisfied the inclusion criteria and had received ANAEMETRO Intravenous infusion at least once.
Arm/Group Title ANAEMETRO Intravenous Infusion (Metronidazole)
Hide Arm/Group Description:
Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 107
Measure Type: Number
Unit of Measure: Participants
ADR 7
Serious ADR 1
2.Secondary Outcome
Title Clinical Response Rate
Hide Description

Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as “effective,” “not effective,” or “indeterminate” by the physician based on clinical symptoms.

Clinical response rate, which was defined as the percentage of participants evaluated as “effective” over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.

Time Frame Maximum 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The clinical efficacy analysis set comprised of participants from the safety analysis set, excluding those with no information of clinical response or infections other than target disease. Participants evaluated as “indeterminate (n=12)” were excluded from the calculation.
Arm/Group Title ANAEMETRO Intravenous Infusion (Metronidazole)
Hide Arm/Group Description:
Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 95
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
95.8
(89.6 to 98.8)
3.Secondary Outcome
Title Clinical Response Rates by Target Diseases
Hide Description

Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as “effective,” “not effective,” or “indeterminate” by the physician based on clinical symptoms.

Clinical response rate, which was defined as the percentage of participants evaluated as “effective” over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.

Participants assessed as "effective" by the following target diseases were counted to assess whether they contribute to the clinical response: anaerobic infection, infectious enterocolitis, amebic dysentery, and the infection with both infectious enterocolitis and amebic dysentery.

Time Frame Maximum 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The clinical efficacy analysis set comprised of participants from the safety analysis set, excluding those with no information of clinical response or infections other than target disease. Participants evaluated as “indeterminate (IND)” were excluded from the calculation.
Arm/Group Title ANAEMETRO Intravenous Infusion (Metronidazole)
Hide Arm/Group Description:
Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician’s discretion.
Overall Number of Participants Analyzed 95
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Anaerobic infection (n=64)excluding IND(n=10) Number Analyzed 64 participants
93.8
(84.8 to 98.3)
Infectious enterocolitis (n=21) excluding IND(n=2) Number Analyzed 21 participants
100.0
(83.9 to 100.0)
Amebic dysentery (n=7) Number Analyzed 7 participants
100.0
(59.0 to 100.0)
Infectious enterocolitis + amebic dysentery (n=3) Number Analyzed 3 participants
100.0
(29.2 to 100.0)
Time Frame Maximum 8 weeks
Adverse Event Reporting Description The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both serious and non-serious events during the study.
 
Arm/Group Title ANAEMETRO Intravenous Infusion (Metronidazole)
Hide Arm/Group Description Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician’s discretion.
All-Cause Mortality
ANAEMETRO Intravenous Infusion (Metronidazole)
Affected / at Risk (%)
Total   3/107 (2.80%) 
Show Serious Adverse Events Hide Serious Adverse Events
ANAEMETRO Intravenous Infusion (Metronidazole)
Affected / at Risk (%)
Total   11/107 (10.28%) 
Blood and lymphatic system disorders   
Disseminated intravascular coagulation * 1  2/107 (1.87%) 
General disorders   
Multiple organ dysfunction syndrome * 1  1/107 (0.93%) 
Hepatobiliary disorders   
Cholecystitis acute * 1  1/107 (0.93%) 
Liver disorder * 1  2/107 (1.87%) 
Infections and infestations   
Bronchopulmonary aspergillosis * 1  1/107 (0.93%) 
Clostridium difficile infection * 1  1/107 (0.93%) 
Pneumonia * 1  1/107 (0.93%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome * 1  1/107 (0.93%) 
Respiratory failure * 1  1/107 (0.93%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.0%
ANAEMETRO Intravenous Infusion (Metronidazole)
Affected / at Risk (%)
Total   2/107 (1.87%) 
Nervous system disorders   
Nausea * 1  2/107 (1.87%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03491228     History of Changes
Other Study ID Numbers: A6831007
First Submitted: March 27, 2018
First Posted: April 9, 2018
Results First Submitted: July 23, 2018
Results First Posted: December 28, 2018
Last Update Posted: December 28, 2018