Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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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 and/or 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

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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 (LPF)will be evaluated.

secondly the frequency of molecular markers for Sulfadoxine-Pyrimethamine drug resistance will be determined.

Conditions

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Malaria

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Sulfadoxine Pyrimethamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female outpatients
* Aged 6 to 59 months
* Body weight between 7.5 to 30 kg
* uncomplicated falciparum malaria with parasitaemia between 1,000/µL and 200,000/µL
* Ability to tolerate oral therapy
* Informed consent, oral agreement of the child if appropriate

Exclusion Criteria

* Still in IPTi trial and/or still in any other intervention trial
* Known G6PD-deficiency
* Presence of severe malnutrition
* Inability to drink or breastfeed
* Recent history of convulsions, lethargy or unconsciousness;
* Signs of severe and complicated
* Mixed/mono infection that includes a non-P. falciparum species.
* Hb \< 7g/dl
* Inability to attend stipulated follow-up visits.
* History of hypersensitivity reactions to the drug being evaluated

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Martin P Grobusch, MD

Role: STUDY_DIRECTOR

Medical Research Unit, Albert Schweitzer Hospital Lambaréné

Saadou Issifou, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Albert Schweitzer Hospital

Locations

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Medical Research Unit of the Albert Schweitzer Hospital

Lambaréné, Moyen-Ogooué Province, Gabon

Site Status

Countries

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Gabon

References

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Mombo-Ngoma G, Oyakhirome S, Ord R, Gabor JJ, Greutelaers KC, Profanter K, Greutelaers B, Kurth F, Lell B, Kun JF, Issifou S, Roper C, Kremsner PG, Grobusch MP. High prevalence of dhfr triple mutant and correlation with high rates of sulphadoxine-pyrimethamine treatment failures in vivo in Gabonese children. Malar J. 2011 May 14;10:123. doi: 10.1186/1475-2875-10-123.

Reference Type DERIVED

PMID: 21569596 (View on PubMed)

Other Identifiers

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IPTi-DRWG- SP Lambaréné

Identifier Type: -

Identifier Source: org_study_id