A Trial of Intermittent Treatment in the Prevention of Malaria in Senegalese Children

NCT00132561 | Completed Phase 2

• 1 other identifier: ITCR 5094
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

In countries of the Sahel and sub-Sahel, malaria transmission is highly seasonal with nearly all infections occurring during a few months of the year. However, mortality and morbidity from malaria may be high during this period, especially in young children who are the group most at risk. Intermittent preventative treatment (IPT) is a new approach to the prevention of malaria in this situation. IPT involves the administration of an anti-malarial to children at risk for malaria at fixed times, even if they are not infected. To investigate how effective this approach might be in Senegal, a trial has been undertaken in which 1136 children aged 6 weeks to 59 months were given a single dose of sulfadoxine pyrimethamine and artesunate on three occasions during a three-month rainy season and the incidence of clinical malaria in these children was compared with that in a group of children who received placebo. Additional observations were made on the incidence of side effects in children in the two groups and on the impact of IPT in children (IPTc) on markers of drug resistance in children whose blood films were positive for Plasmodium falciparum.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• Clinical episodes of malaria

Secondary Outcomes (2)

• Side effects

• Change in the prevalence of drug resistance markers

Interventions

Sulfadoxine/pyrimethamine and artesunate DRUG

Eligibility Criteria

• Age: 6 Weeks - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ages 6 weeks to 59 months
• Residence in the study area
• Informed consent

You may not qualify if:

• Known allergy to study drugs
• Serious underlying illness

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Institut de Recherche pour le Developpement, Senegal: collaborator
• Institut de Recherche pour le Developpement: collaborator
• Cheikh Anta Diop University, Senegal: collaborator
• Ministry of Health, Senegal: collaborator

Study Sites (1)

Institut de recherche pour le developpement

Dakar, BP 1386, Senegal

Location

Related Publications (1)

• Cisse B, Sokhna C, Boulanger D, Milet J, Ba el H, Richardson K, Hallett R, Sutherland C, Simondon K, Simondon F, Alexander N, Gaye O, Targett G, Lines J, Greenwood B, Trape JF. Seasonal intermittent preventive treatment with artesunate and sulfadoxine-pyrimethamine for prevention of malaria in Senegalese children: a randomised, placebo-controlled, double-blind trial. Lancet. 2006 Feb 25;367(9511):659-67. doi: 10.1016/S0140-6736(06)68264-0.

  PMID: 16503464 RESULT

MeSH Terms

Conditions

Malaria

Interventions

sulfadoxine-pyrimethamine-artesunate

Condition Hierarchy (Ancestors)

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

Study Officials

• Badara Cisse, MD

  Institut de Recherche pour le Developpement, Senegal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2005
• First Posted: August 22, 2005
• Study Start: June 1, 2002
• Study Completion: December 1, 2003
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

SE (1)