Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453856
Status:
TERMINATED
Last Update Posted:
2007-08-10
First Post:
2007-03-28
Brief Title:
Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children
Sponsor:
Albert Schweitzer Hospital
Organization:
Albert Schweitzer Hospital
Study Overview
Official Title:
Efficacy of Sulfadoxine-Pyrimethamine in the Treatment of Symptomatic Uncomplicated Plasmodium Falciparum Malaria Among 6-59 Month Old Children in Lambaréné
Status:
TERMINATED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated because of Early Treatment Failure in childThe justification for this decision are concerns about safety of children
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IPTi a strategy whereby infants are provided treatment doses of antimalarials at routine vaccination visits has been shown to significantly reduce malaria and anemia in two studies in Tanzania However the results obtained in Gabon are not similar Many factors are likely to influence the efficacy or effectiveness IPTi It is reasonable to assume that the efficacy of IPTi will be influenced markedly by the sensitivity of Plasmodium falciparum to the antimalarial drug Sulfadoxine-Pyrimethamine used for IPTi
In order to interpret the results of individual IPTi trials conducted by the IPTi Consortium and to provide information for policy makers regarding the predicted efficacy of IPTi it is essential to obtain information on antimalarial drug sensitivity of Sulfadoxine-Pyrimethamine now that the IPTi trial has been conducted The simplest and most universally accepted measure of testing for antimalarial drug efficacy is the in vivo efficacy study which follows a standardized World Health Organization protocol
A second reason for evaluating drug resistance as an adjunct to the IPTi trials is to determine if the intervention increases the carriage andor spread of drug resistant P falciparum parasites
Thirdly the overall effect at the community level of selection of resistant genotypes in IPTi-recipients is unclear
In order to interpret the results of individual IPTi trials conducted by the IPTi Consortium and to provide information for policy makers regarding the predicted efficacy of IPTi it is essential to obtain information on antimalarial drug sensitivity of Sulfadoxine-Pyrimethamine now that the IPTi trial has been conducted The simplest and most universally accepted measure of testing for antimalarial drug efficacy is the in vivo efficacy study which follows a standardized World Health Organization protocol
A second reason for evaluating drug resistance as an adjunct to the IPTi trials is to determine if the intervention increases the carriage andor spread of drug resistant P falciparum parasites
Thirdly the overall effect at the community level of selection of resistant genotypes in IPTi-recipients is unclear
Detailed Description:
Administration of standard single oral dose of sulfadoxine-pyrimethamine to children aged 6-59 month old children in Lambaréné at enrolment if eligible according to the approved protocol
139 subjects will be enrolled and treated with Sulfadoxine-Pyrimethamine for uncomplicated malaria Thereafter each subject will be followed according to the approved protocol
The proportion of subjects with Adequate Clinical and Parasitological response ACPR by day 28 Early Treatment Failure ETF Late Clinical Failure LCF and Late Parasitological Failure LPFwill be evaluated
secondly the frequency of molecular markers for Sulfadoxine-Pyrimethamine drug resistance will be determined
139 subjects will be enrolled and treated with Sulfadoxine-Pyrimethamine for uncomplicated malaria Thereafter each subject will be followed according to the approved protocol
The proportion of subjects with Adequate Clinical and Parasitological response ACPR by day 28 Early Treatment Failure ETF Late Clinical Failure LCF and Late Parasitological Failure LPFwill be evaluated
secondly the frequency of molecular markers for Sulfadoxine-Pyrimethamine drug resistance will be determined
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