Suspended

Comparative Study of Cotrifazid, Mefloquine, and Quinine+SP for Recurrent Uncomplicated Malaria

What is being tested

Data Collection

Who is being recruted

Vector Borne Diseases+3

+ Mosquito-Borne Diseases

+ Infections

Over 6 Months

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: April 2000

See protocol details

Summary

Principal SponsorCenter for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2000

Actual date on which the first participant was enrolled.

This study is a comparative trial happening in Papua New Guinea, focusing on treating recurrent uncomplicated malaria. It aims to find a safe and effective treatment for malaria that has become resistant to current medications. The trial involves patients of all ages who are dealing with this type of malaria. The importance of this study lies in its potential to improve malaria treatment and address the challenge of drug-resistant malaria, thereby enhancing patient care in this region. Patients participating in this trial receive one of three treatments: Cotrifazid, mefloquine, or the standard treatment of quinine+sulfadoxine/pyrimethamine (SP). The study measures the effectiveness of these treatments by monitoring the rate of clinical and/or parasitological failure at day 14, as well as the incidence of clinical and laboratory adverse events. This helps to understand the safety and efficacy of each treatment option.

Official TitleA Randomised Safety and Efficacy Trial of Rifampicin/Cotrimoxazole/Isoniazid Versus Mefloquine or Quinine+SP Against Resistant Malaria in Papua New Guinea

NCT00322907

Principal SponsorCenter for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

330 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 6 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vector Borne DiseasesMosquito-Borne DiseasesInfectionsMalariaParasitic DiseasesProtozoan Infections

Criteria

4 inclusion criteria required to participate

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)

Who had already been treated for malaria in the 28 days before

If the subject or legal guardian (for children) gave informed consent

If the clinician in charge would have given the standard treatment for resistant malaria independent of the study

4 exclusion criteria prevent from participating

The clinician preferred to use quinine for whatever reason

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)

Was pregnant

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Health centers

Madang and Maprik, Papua New GuineaOpen Health centers in Google Maps

SuspendedOne Study Center