The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- parasite clearance time [ Time Frame: 35 days ] [ Designated as safety issue: No ]
- recrudescence rate [ Time Frame: 35 days ] [ Designated as safety issue: No ]
- 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 |
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 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 Antipyretics Physiological Effects of Drugs Pharmacologic Actions |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013