Cotrifazid Safety and Efficacy Against Malaria

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. Identifier: NCT00322907
Recruitment Status : Terminated
First Posted : May 8, 2006
Last Update Posted : May 8, 2006
Papua New Guinea Institute of Medical Research
Swiss Tropical & Public Health Institute
Information provided by:
Policlinique Médicale Universitaire

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)

Condition or disease Intervention/treatment Phase
Clinical Malaria Drug: Cotrifazid vs mefloquine or quinine+SP Phase 2

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2000
Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Primary Outcome Measures :
  1. Clinical treatment failure rate on day 14.
  2. Incidence of adverse events.

Secondary Outcome Measures :
  1. Parasitological failure rate on day 14
  2. Fever clearance time
  3. Parasite clearance time
  4. Symptoms clearance time
  5. Occurrence of complications

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00322907

Papua New Guinea
Health centers
Madang and Maprik, Madang and East Sepik Province, Papua New Guinea
Sponsors and Collaborators
Policlinique Médicale Universitaire
Papua New Guinea Institute of Medical Research
Swiss Tropical & Public Health Institute
Principal Investigator: Blaise Genton, MD, PhD Swiss Tropical & Public Health Institute Identifier: NCT00322907     History of Changes
Other Study ID Numbers: Fatol 1
First Posted: May 8, 2006    Key Record Dates
Last Update Posted: May 8, 2006
Last Verified: October 1999

Keywords provided by Policlinique Médicale Universitaire:
clinical trial

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Sensory System Agents
Antitubercular Agents
Anti-Bacterial Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Antibiotics, Antitubercular
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors