Cotrifazid Safety and Efficacy Against Malaria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2003-01-31

Brief Summary

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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

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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

Conditions

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Clinical Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cotrifazid vs mefloquine or quinine+SP

Intervention Type DRUG

Eligibility Criteria

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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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Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Blaise Genton, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Swiss Tropical & Public Health Institute

Locations

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Health centers

Madang and Maprik, Madang and East Sepik Province, Papua New Guinea

Site Status

Countries

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Papua New Guinea

Other Identifiers

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Fatol 1

Identifier Type: -

Identifier Source: org_study_id