Back to resultsCotrifazid Safety and Efficacy Against Malaria
Primary Purpose
Clinical Malaria
Status
Terminated
Phase
Phase 2
Locations
Papua New Guinea
Study Type
Interventional
Intervention
Cotrifazid vs mefloquine or quinine+SP
Sponsored by
About this trial
This is an interventional treatment trial for Clinical Malaria focused on measuring malaria, treatment, cotrifazid, clinical trial, efficacy
Eligibility Criteria
Inclusion Criteria: All subjects > 6 months of age who presented at the centres and who were diagnosed with malaria (history of fever, OptiMAL® test positive, no other major symptom) and who had already been treated for malaria in the 28 days before, could be included in the study, if the subject or legal guardian (for children) gave informed consent and if the clinician in charge would have given the standard treatment for resistant malaria independent of the study - Exclusion Criteria: A subject was not to be included if the clinician preferred to use quinine for whatever reason, if the patient had one of the symptoms or signs of complicated or severe malaria (i.e. history of recent convulsion, any neurological sign or impairment of consciousness, heavy vomiting, haemoglobinuria, respiratory distress, bleeding, circulatory collapse, shock, jaundice, haemoglobin < 5 g/dl), had contra-indications for mefloquine (history of psychiatric disorder, epilepsy), or was pregnant. -
Sites / Locations
- Health centers
Outcomes
Primary Outcome Measures
Clinical treatment failure rate on day 14.
Incidence of adverse events.
Secondary Outcome Measures
Parasitological failure rate on day 14
Fever clearance time
Parasite clearance time
Symptoms clearance time
Occurrence of complications
Full Information
NCT ID
NCT00322907
First Posted
May 5, 2006
Last Updated
May 5, 2006
Sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Collaborators
Papua New Guinea Institute of Medical Research, Swiss Tropical & Public Health Institute
1. Study Identification
Unique Protocol Identification Number
NCT00322907
Brief Title
Cotrifazid Safety and Efficacy Against Malaria
Official Title
A Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea
Study Type
Interventional
2. Study Status
Record Verification Date
October 1999
Overall Recruitment Status
Terminated
Study Start Date
April 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Collaborators
Papua New Guinea Institute of Medical Research, Swiss Tropical & Public Health Institute
4. Oversight
5. Study Description
Brief Summary
The purpose of this study was to assess the safety and efficacy of Cotrifazid to treat uncomplicated resistant malaria and to compare the outcome with mefloquine or quinine+sulfadoxine/pyrimethamine (SP)
Detailed Description
Design: Open-label, block-randomised, comparative, multicentric trial. Setting: Four primary care health facilities, two in urban and two in rural areas of Madang and East Sepik Province, Papua New Guinea.
Participants: Patients of all ages with recurrent uncomplicated malaria Intervention: Random assignment to receive either Cotrifazid, mefloquine or the standard treatment of quinine+sulfadoxine/pyrimethamine (SP).
Outcome measures: Incidence of clinical and laboratory adverse events; rate of clinical and/or parasitological failure at day 14
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Malaria
Keywords
malaria, treatment, cotrifazid, clinical trial, efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cotrifazid vs mefloquine or quinine+SP
Primary Outcome Measure Information:
Title
Clinical treatment failure rate on day 14.
Title
Incidence of adverse events.
Secondary Outcome Measure Information:
Title
Parasitological failure rate on day 14
Title
Fever clearance time
Title
Parasite clearance time
Title
Symptoms clearance time
Title
Occurrence of complications
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All subjects > 6 months of age who presented at the centres and who were diagnosed with malaria (history of fever, OptiMAL® test positive, no other major symptom) and who had already been treated for malaria in the 28 days before, could be included in the study, if the subject or legal guardian (for children) gave informed consent and if the clinician in charge would have given the standard treatment for resistant malaria independent of the study -
Exclusion Criteria:
A subject was not to be included if the clinician preferred to use quinine for whatever reason, if the patient had one of the symptoms or signs of complicated or severe malaria (i.e. history of recent convulsion, any neurological sign or impairment of consciousness, heavy vomiting, haemoglobinuria, respiratory distress, bleeding, circulatory collapse, shock, jaundice, haemoglobin < 5 g/dl), had contra-indications for mefloquine (history of psychiatric disorder, epilepsy), or was pregnant.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blaise Genton, MD, PhD
Organizational Affiliation
Swiss Tropical & Public Health Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health centers
City
Madang and Maprik
State/Province
Madang and East Sepik Province
Country
Papua New Guinea
12. IPD Sharing Statement
Learn more about this trial
Cotrifazid Safety and Efficacy Against Malaria
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