Efficacy of Sulfadoxine-Pyrimethamine for Treating Malaria in Gabonese Children

NCT00453856 | Terminated Phase 4

• 1 other identifier: IPTi-DRWG- SP Lambaréné
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Malaria

Keywords

Malaria; Sulfadoxine; Pyrimethamine; Resistance; Gabon

Outcome Measures

Primary Outcomes (1)

• Measure the clinical and parasitological efficacy of SP among patients aged between 6-59 months suffering from uncomplicated P falciparum malaria,

Secondary Outcomes (1)

• Determine the frequency of molecular markers for drug resistance

Interventions

Sulfadoxine Pyrimethamine DRUG

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Schweitzer Hospital, Netherlands: lead
• Albert Schweitzer Hospital: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Medical Research Unit of the Albert Schweitzer Hospital

Lambaréné, Moyen-Ogooué Province, B.P. 118, Gabon

Location

Related Publications (1)

• 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.

  PMID: 21569596 DERIVED

Related Links

• (Homepage of the Medical Research Unit, Lambaréné)

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Martin P Grobusch, MD

  Medical Research Unit, Albert Schweitzer Hospital Lambaréné

  STUDY DIRECTOR

• Saadou Issifou, MD MSc

  Albert Schweitzer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: UNKNOWN

Study Record Dates

• First Submitted: March 28, 2007
• First Posted: March 29, 2007
• Study Start: March 1, 2007
• Last Updated: August 10, 2007

Record last verified: 2007-08

Locations

GA (1)