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Cotrifazid Safety and Efficacy Against Malaria

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00322907
First Posted: May 8, 2006
Last Update Posted: May 8, 2006
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.
Collaborators:
Papua New Guinea Institute of Medical Research
Swiss Tropical & Public Health Institute
Information provided by:
Policlinique Médicale Universitaire
  Purpose
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 Intervention Phase
Clinical Malaria Drug: Cotrifazid vs mefloquine or quinine+SP Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Policlinique Médicale Universitaire:

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

Estimated Enrollment: 330
Study Start Date: April 2000
Estimated Study Completion Date: January 2003
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

  Eligibility

Information from the National Library of Medicine

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00322907


Locations
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
Investigators
Principal Investigator: Blaise Genton, MD, PhD Swiss Tropical & Public Health Institute
  More Information

ClinicalTrials.gov Identifier: NCT00322907     History of Changes
Other Study ID Numbers: Fatol 1
First Submitted: May 5, 2006
First Posted: May 8, 2006
Last Update Posted: May 8, 2006
Last Verified: October 1999

Keywords provided by Policlinique Médicale Universitaire:
malaria
treatment
cotrifazid
clinical trial
efficacy

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