Suspended

The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau

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What is being tested

acetaminophen (paracetamol)

+ Placebo

DrugOther
Who is being recruted

Vector Borne Diseases+3

+ Mosquito-Borne Diseases

+ Infections

Until 15 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorBandim Health Project
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

A Cochrane Review was unable to show a superior antipyretic effect of paracetamol compared with placebo in febrile children. Recent research suggests that the time to parasite clearance in non-severe malaria is longer in children being given paracetamol. As the costs associated with the use of paracetamol is not trivial and the risk of adverse effects is not negligible, we want to evaluate the effects of paracetamol on: * the well-being of the child; * the parasite clearance time; and * the recrudescence rate. Children presenting at Bandim Health Centre with symptoms of malaria and a malaria film showing mono-infection with P.falciparum will, following consent to participate, randomly be allocated to treatment with chloroquine and paracetamol or with chloroquine and placebo. Blood samples will be obtained daily for the first 4 days. The children will be visited and a malaria film taken on day 7 and then weekly until day 35. On inclusion and whenever parasitaemia is detected a capillary blood sample will be taken for PCR analyses to be able to distinguish re-infection from recrudescence. During follow-up children are recommended to present at the health centre in case of persistent fever or any other symptoms. Examination and treatment will be free of charge. Whenever a child has re-infection sulfadoxine/pyrimethamine will be used for re-treatment following the recommendation of the National malaria Programme. After the inclusion of 80 children a preliminary analysis will be performed. If 50% or more of the children in any of the study arms have reappearing parasitaemia the study will be terminated. If the parasite clearance time and especially the recrudescence rate is higher for children being given paracetamol the current recommendation from the National Malaria Programme should be reconsidered. If children treated with paracetamol feel better during the acute illness making it more likely for them to have en adequate intake of food and liquid this benefit should be considered in the evaluation of the current recommendations.

Official TitleThe Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau
NCT00137566
Principal SponsorBandim Health Project
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.

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.

Until 15 Years

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

5 inclusion criteria required to participate
Symptoms suggestive of malaria

At least 20 P. falciparum parasites per 200 leukocytes

Live in Bandim (to enable follow-up)

15 years of age

Show More Criteria

2 exclusion criteria prevent from participating
Severely ill children considered to need the services of a hospital by the doctor in charge

Previous idiosyncratic reactions to chloroquine or paracetamol

Study Plan

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

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Paracetamol as per protocol

Group II

Placebo
Inactive placebo as per protocol.

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

Bandim Health Project

Apartado 861, Guinea-BissauOpen Bandim Health Project in Google Maps
SuspendedOne Study Center