Cotrifazid Safety and Efficacy Against Malaria

Sponsor

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland (Other)

Overall Status

Terminated

CT.gov ID

NCT00322907

Collaborator

Papua New Guinea Institute of Medical Research (Other), Swiss Tropical & Public Health Institute (Other)

330

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

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)

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 Design

Study Type:

Interventional

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 :

Apr 1, 2000

Study Completion Date :

Jan 1, 2003

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Health centers	Madang and Maprik	Madang and East Sepik Province	Papua New Guinea

Sponsors and Collaborators

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Papua New Guinea Institute of Medical Research
Swiss Tropical & Public Health Institute