Antimalarial Treatments for Clearing Low Density P. Falciparum and Its Impact on Malaria Transmission

Plasmodium Falciparum Clinical Trial

Official title:

Validation of the Use of Istope-Based Molecular Techniques for Malaria Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646126
• Other study ID #: SUD 6/025
• Status: Completed
• Phase: Phase 3
• First received: March 25, 2008
• Last updated: March 27, 2008
• Start date: August 2005

Study information

• Verified date: August 2005
• Source: Tropical Medicine Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sudan: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The malaria parasite Plasmodium falciparum remains at sub-patent level throughout the dry season in areas of seasonal malaria transmission. Targeting this parasite reservoir before the transmission season could be a good strategy for malaria control. We are conducting a randomized double blind placebo controlled mass drug administration trial in eight village to clear the dry season low level parasitaemia with an ultimate aim of controlling malaria in eastern Sudan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• All residents of the 8 villages

Exclusion Criteria:

• Pregnancy

• History of allergy to sulfa drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asymptomatic Parataemia
• Parasitemia
• Plasmodium Falciparum
• Sub Patent Parasitaemia

Intervention

Drug:
• Sulfadoxine / Pyrimethamine (SP) plus artesunate (AS)
Standard three day regimen
• placebo tablet similar to active drug in shape and size
Dosage similar to active drug(standard three days regimen)

Locations

Country	Name	City	State
Sudan	Tropical Medicine Research Institute	Khartoum

Sponsors (3)

Lead Sponsor	Collaborator
Tropical Medicine Research Institute	International Atomic Energy Agency, London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parsitaemia detected during the transmission season among dry season PCR negative persons in the intervention and control villages		October to December 2006
Secondary	1. Malaria prevalence during the transmission season 2. Frequency of mutation in drug resistance genes