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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Bandim Health Project.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00137566
First received: August 28, 2005
Last updated: July 6, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Malaria
Falciparum
Drug: acetaminophen (paracetamol)
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • parasite clearance time [ Time Frame: 35 days ] [ Designated as safety issue: No ]
  • recrudescence rate [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • well-being of the child [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Study Start Date: May 2004
Estimated Study Completion Date: January 2010
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137566

Locations
Guinea-Bissau
Bandim Health Project
Apartado 861, Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Investigators
Study Director: Peter Aaby, Professor Bandim Health Project
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Poul-Erik Kofoed, Bandim Health Project
ClinicalTrials.gov Identifier: NCT00137566     History of Changes
Other Study ID Numbers: PSB-2004-paracetamol
Study First Received: August 28, 2005
Last Updated: July 6, 2010
Health Authority: Guinea-Bissau: Ministry of Health
Denmark: Ethics Committee

Keywords provided by Bandim Health Project:
malaria
treatment
paracetamol
chloroquine
Guinea-Bissau
children
P.falciparum

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 18, 2014