Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426439
Status:
COMPLETED
Last Update Posted:
2011-01-04
First Post:
2007-01-23
Brief Title:
Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
Chloroquine and Coartem for Treatment of Symptomatic Children With Plasmodium Falciparum in Guinea Bissau
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the efficacy of treatment with artemether-lumefantrine as compared to chloroquine in the dose of 50 mgkg 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
Detailed Description:
This study compares treatment of uncomplicated malaria in children in Guinea-Bissau with artemether-lumefantrine Coartem with that of treatment with chloroquine 50 mgkg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None