Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau

This study has been completed.
Sponsor:
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00426439
First received: January 23, 2007
Last updated: January 2, 2011
Last verified: January 2011

January 23, 2007
January 2, 2011
December 2006
November 2008   (final data collection date for primary outcome measure)
Parasite reappearance rate, [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Parasite reappearance rate,
  • hospitalization during follow-up,
  • haemoglobin changes
Complete list of historical versions of study NCT00426439 on ClinicalTrials.gov Archive Site
  • genetic markers of resistance [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • recrudescence and re-infection rates [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Hospitalisation during follow-up [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • Haemoglobin changes [ Time Frame: 70 days ] [ Designated as safety issue: No ]
  • genetic markers of resistance
  • recrudescence and re-infection rates
Not Provided
Not Provided
 
Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau
Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau.

This study will evaluate the efficacy of treatment with artemether-lumefantrine as compared to chloroquine in the dose of 50 mg/kg for treatment of malaria in children in Guinea-Bissau. The genetic basis of the parasites for developing resistance will be examined. Children coming to one of the Health Centres with symptoms of malaria and a positive malaria test will be included. The children will be followed weekly until day 70. In case of reappearance of parasites the child will be re-treated with the opposite study drug.

This study compares treatment of uncomplicated malaria in children in Guinea-Bissau with artemether-lumefantrine (Coartem) with that of treatment with chloroquine 50 mg/kg. Furthermore, the genetic basis of anti-malarial resistance in Guinea-Bissau will be studied by analyzing specific single nucleotide polymorphisms in pfcrt and pfmdr1 in blood samples from this in vivo trial. We also intend to study whether the recent report that chloroquine sensitive parasites are selected at recrudescence after Coartem is confirmed in Bissau.

Following consent to participate, children visiting one of the Health Centres in the study area with mono-infection with Plasmodium falciparum are by block-randomization allocated to one of the treatment groups. The treatment is given supervised by one of the health workers and malaria film taken on day 2 and 3. The children are visited and malaria films obtained once weekly until day 70. On day seven, 100 microliter of capillary blood are drawn for analyses of analyses of drug concentrations in whole blood. On inclusion and whenever a child has recurrent parasitaemia, a filter-paper blood-sample is collected for later PCR analysis. On the day of inclusion, on day 42 and on day 70 the haemoglobin level is measured.

If parasites reappear in 50% or more of at least 40 children in one of the treatment groups this treatment arm should be terminated. During the study parents are recommended to bring the child to the health centre in case of any illness. Participating children will be examined and treated free of charge. The opposite study drug will be used for re-treatment of children in case of recrudescence, and the child will be followed as previously planned.

The results from this study could be used for the planning of the recommendations for treatment of malaria in Guinea-Bissau. It will provide the National Malaria Programme with information of the efficacy of Coartem before it is implemented.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria, Falciparum
  • Drug: Chloroquine
    Chloroquine tablets gives as 50 mg/kg divided into 6 doses giver twice a day for 3 days.
  • Drug: Artemether-lumefantrine (Coartem)
    Will be dosed according to the recommendations of WHO. Will be given at time: 0 h, 8 h, 24 h, 36 h,48 h and 60 h. The dosage will be according to bodyweight of the child as follows: 5-14 kg: 1 tablet, 15-24 kg: 2 tablets, 25-34 kg: 3 tablets, < 34 kg: 4 tablets.
    Other Name: Brand name: Coartem.
  • Experimental: 1 Coartem
    Treatment of documented malaria in children following the dosages recommended by the manufacturer.
    Interventions:
    • Drug: Chloroquine
    • Drug: Artemether-lumefantrine (Coartem)
  • Active Comparator: 2 Chloroquine
    The antimalarial actually used in Guinea-Bissau is the dosage of 50 mg/kg given twice a day for 3 days.
    Interventions:
    • Drug: Chloroquine
    • Drug: Artemether-lumefantrine (Coartem)
Ursing J, Kofoed PE, Rodrigues A, Blessborn D, Thoft-Nielsen R, Björkman A, Rombo L. Similar efficacy and tolerability of double-dose chloroquine and artemether-lumefantrine for treatment of Plasmodium falciparum infection in Guinea-Bissau: a randomized trial. J Infect Dis. 2011 Jan 1;203(1):109-16. doi: 10.1093/infdis/jiq001.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children presenting at one of the health centres in the study area
  • Symptoms suggestive of malaria
  • At least 20 P.falciparum parasites per 200 leucocytes
  • Living in the study area (to enable follow-up)

Exclusion Criteria:

  • Danger signs
  • By the responsible doctor evaluated to need to be transferred to the national hospital as an in-patient
  • Previous idiosyncratic reactions to any of the study drugs
Both
6 Months to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Guinea-Bissau
 
NCT00426439
PSB-2006-Coartem
Yes
Dr. Poul-Erik Kofoed, Bandim Heath Project
Bandim Health Project
Not Provided
Study Director: Peter Aaby Bandim Health Project
Bandim Health Project
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP