Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137514
Status:
COMPLETED
Last Update Posted:
2008-04-08
First Post:
2005-08-28
Brief Title:
Chloroquine and Amodiaquine for Treatment of Malaria in Children
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
Chloroquine and Amodiaquine for Treatment of Symptomatic Children With Plasmodium Malaria in Guinea-Bissau
Status:
COMPLETED
Status Verified Date:
2008-04
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 the treatment recommended by the National Malaria Programme in Guinea-Bissau as compared to a higher dose of chloroquine and to another anti-malarial drug amodiaquine The genetic basis of the parasites for developing resistance will be examined Children coming to Bandim Health Centre with symptoms of malaria and a positive malaria test will be included The children will be visited and malaria films will be obtained weekly until day 35 In case of a reappearance of parasites the children will be re-treated with sulfadoxinepyrimethamine
Detailed Description:
This study compares treatment of uncomplicated malaria in children in Guinea-Bissau as recommended by the national malaria programme chloroquine in a total dose of 25 mgkg either with a total dose of 50 mgkg chloroquine or with a total dose of 15 or 30 mg of amodiaquine As both annual in vitro studies from 1992 to 2004 except 1998 1999 and several in-vivo studies from Guinea-Bissau indicate a fairly stable chloroquine resistance prevalence another aim of this study is to evaluate the genetic basis of chloroquine resistance in Guinea-Bissau by analyzing specific single nucleotide polymorphisms in pfcrt and pfmdr1 in blood samples from this in vivo trial
Following consent to participate children visiting the Bandim Health Centre on the outskirts of Bissau with mono-infection with Plasmodium falciparum are by block-randomization allocated to one of the four different treatment groups The treatment is given supervised by one of the health workers The children are visited and malaria films obtained on day 2 and day 7 and then once weekly until day 35 On day seven 100 microliters of capillary blood are drawn for analyses of chloroquine or amodiaquine concentrations in whole blood Whenever a child has recurrent parasitaemia a filter-paper blood-sample is collected for later PCR analysis
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 Bandim Health Centre in case of any illness Participating children will be examined and treated free of charge Following the recommendations of the national Malaria Programme sulfadoxinepyrimethamine will be used for re-treatment of children in case of recrudescence
The results from this study could be used when giving the needed new recommendations for treatment of malaria in Guinea-Bissau If still effective mono-therapy with a higher dose of chloroquine could be used until the introduction of a better treatment is possible When artemisinine combination therapy is going to be introduced in Guinea-Bissau the results could be helpful in deciding if amodiaquine should be considered as the partner drug - and in which dose
Following consent to participate children visiting the Bandim Health Centre on the outskirts of Bissau with mono-infection with Plasmodium falciparum are by block-randomization allocated to one of the four different treatment groups The treatment is given supervised by one of the health workers The children are visited and malaria films obtained on day 2 and day 7 and then once weekly until day 35 On day seven 100 microliters of capillary blood are drawn for analyses of chloroquine or amodiaquine concentrations in whole blood Whenever a child has recurrent parasitaemia a filter-paper blood-sample is collected for later PCR analysis
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 Bandim Health Centre in case of any illness Participating children will be examined and treated free of charge Following the recommendations of the national Malaria Programme sulfadoxinepyrimethamine will be used for re-treatment of children in case of recrudescence
The results from this study could be used when giving the needed new recommendations for treatment of malaria in Guinea-Bissau If still effective mono-therapy with a higher dose of chloroquine could be used until the introduction of a better treatment is possible When artemisinine combination therapy is going to be introduced in Guinea-Bissau the results could be helpful in deciding if amodiaquine should be considered as the partner drug - and in which dose
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-126 SAREC | None | None | None |