Cotrifazid Safety and Efficacy Against Malaria

This study has been terminated.
Sponsor:
Collaborators:
Papua New Guinea Institute of Medical Research
Swiss Tropical & Public Health Institute
Information provided by:
Policlinique Médicale Universitaire
ClinicalTrials.gov Identifier:
NCT00322907
First received: May 5, 2006
Last updated: NA
Last verified: October 1999
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00322907     History of Changes
Other Study ID Numbers: Fatol 1
Study First Received: May 5, 2006
Last Updated: May 5, 2006
Health Authority: Papua New Guinea: Ministry of Health

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

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Mefloquine
Quinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on July 23, 2014