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

July 6, 2010 updated by: Bandim Health Project

The National Malaria Programme in Guinea-Bissau recommends paracetamol for all children treated for malaria. We, the investigators of the Bandim Health Project, want to evaluate whether this treatment has any effect on:

  • the well-being of the child;
  • the parasite clearance time; and
  • the rate of a re-appearance of parasites during 35 days of follow-up.

Children presenting at Bandim Health Centre with malaria will be treated with chloroquine plus paracetamol or chloroquine plus placebo. Blood samples will be obtained daily for the first 4 days and then once a week until day 35.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guinea-Bissau
    • Bissau
      • Apartado 861, Bissau, Guinea-Bissau
        • Bandim Health Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • < 15 years of age
  • Presenting at Bandim Health Centre
  • Symptoms suggestive of malaria
  • At least 20 P. falciparum parasites per 200 leukocytes
  • Live in Bandim (to enable follow-up)

Exclusion Criteria:

  • 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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Paracetamol
Paracetamol as per protocol
Drug: acetaminophen (paracetamol)
Paracetamol tablets, 50 mg/kg/day for 3 days.
Placebo Comparator: 2 Placebo
Inactive placebo as per protocol.
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
parasite clearance time
Time Frame: 35 days
35 days
recrudescence rate
Time Frame: 35 days
35 days

Secondary Outcome Measures

Outcome Measure
Time Frame
well-being of the child
Time Frame: 35 days
35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bandim Health Project

Investigators

  • Study Director: Peter Aaby, Professor, Bandim Health Project

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

August 28, 2005

First Submitted That Met QC Criteria

August 28, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSB-2004-paracetamol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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