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Lapdap and Coartemether for Uncomplicated Malaria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118794
First Posted: July 12, 2005
Last Update Posted: February 1, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medical Research Council
National Malaria Control Programme, The Gambia
Information provided by:
London School of Hygiene and Tropical Medicine
July 1, 2005
July 12, 2005
February 1, 2006
September 2004
Not Provided
Clinical failure by day 28
Same as current
Complete list of historical versions of study NCT00118794 on ClinicalTrials.gov Archive Site
  • Incidence of severe anaemia by day 28
  • Compliance
  • Incidence of adverse events
  • Parasitological failure by day 28
  • Clinical and parasitological failure rates by day 14
  • Fall in Hb of 2g/dl or more from screening value
Same as current
Not Provided
Not Provided
 
Lapdap and Coartemether for Uncomplicated Malaria
Randomized Trial of the Safety and Effectiveness of Lapdap and Coartemether for Uncomplicated Malaria in Operational Settings
Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.
Patients with uncomplicated malaria will be recruited at three health centres in the Gambia. Children aged 6 months to 10 years presenting with a history of illness, who have a fever or recent history of fever, will be screened; those with uncomplicated malaria, a positive blood smear with a parasite density of 500 to 200,000 parasites/µl, monoinfection with P. falciparum, and a packed cell volume of >=20%, will be invited to enroll into the study and if consent is given, will be randomized to receive three daily doses of lapdap, or a six-dose course of Coartem. The first dose will be given by the mother under direct observation by the dispensing nurse; subsequent doses will be given at home unsupervised. Children will be followed up actively three times; on day 3, to assess adherence to the treatment regimen, and on days 14 and 28, to assess parasitological and haematological recovery. The mother/caregiver of the child will be encouraged to bring the child to the clinic if the child does not improve or if she is concerned about the child’s health. On day 3, the parent/caregiver will be visited at home (after the last dose should have been taken) in order to check for any leftover medication, and to ask about compliance and adverse reactions. A finger prick blood sample will be taken for Hb measurement by haemocue in the field and for a filter paper sample for measurement of drug concentration. The investigators will employ a longitudinal randomized design, whereby subsequent episodes of malaria will be treated according to the original randomization. This will enable better assessment of cumulative effects of repeated treatments on anaemia and on tolerability. Since patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap, the investigators will determine the G6PD genotype and enzymatic activity, in order to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malaria
  • Drug: Chlorproguanil-dapsone (Lapdap)
  • Drug: Lumefantrine-artemether (Coartemether )
Not Provided
Dunyo S, Sirugo G, Sesay S, Bisseye C, Njie F, Adiamoh M, Nwakanma D, Diatta M, Janha R, Sisay Joof F, Temple B, Snell P, Conway D, Walton R, Cheung YB, Milligan P. Randomized trial of safety and effectiveness of chlorproguanil-dapsone and lumefantrine-artemether for uncomplicated malaria in children in the Gambia. PLoS One. 2011;6(6):e17371. doi: 10.1371/journal.pone.0017371. Epub 2011 Jun 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
June 2005
Not Provided

Inclusion Criteria:

  • presentation at health centre with febrile illness
  • monoinfection with P falciparum
  • parasitaemia >=500/microlitre
  • fever or history of fever

Exclusion Criteria:

  • signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia >200,000/ul)
  • severe malnutrition
  • clinically evident concomitant disease
  • PCV <20%
  • history of allergy to the study medications
  • residence outside the study area and hence difficult to follow up
Sexes Eligible for Study: All
6 Months to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Gambia
 
 
NCT00118794
SCC975
SCC975
Not Provided
Not Provided
Not Provided
Not Provided
London School of Hygiene and Tropical Medicine
  • Medical Research Council
  • National Malaria Control Programme, The Gambia
Principal Investigator: Paul J Milligan, BSc MSc PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Sam K Dunyo, MD PhD Medical Research Council
London School of Hygiene and Tropical Medicine
January 2005

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