CQSP in Malawi: Chloroquine and Sulfadoxine-pyrimethamine Efficacy for the Treatment of Malaria in Malawi

NCT00125489 | Completed Phase 4

• 1 other identifier: 05-0012
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to find out how well chloroquine works as a drug to treat malaria in children, compared to the standard malaria treatment in Malawi. In preparation for a longer study of the malaria treatment medication chloroquine alone and in combination with other drugs, a shorter pre-study will be done to compare the anti-malarial effectiveness of chloroquine versus sulfadoxine-pyrimethamine (SP), the standard treatment in Malawi. Two hundred ten children, ages 6 months to 12 years, around Blantyre, Malawi, will be given standard dosing of either chloroquine or SP when they come to the Ndirande Health Centre with signs or symptoms consistent with malaria. The first 30 participants in each treatment group will remain under continuous observation at the health center so that the researchers can monitor their response to the medication until the infection goes away. The participants will be followed for 28 days to see if the the treatment works or fails.

Conditions

Malaria; Plasmodium Falciparum Malaria

Keywords

chloroquine, malaria, sulfadoxine/pyrimethamine, Malawi

Interventions

chloroquine sulfate DRUG

sulfadoxine/pyrimethamine DRUG

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged \>= 6 months to 12 years presenting to Ndirande Health Centre with signs or symptoms consistent with malaria including but not limited to one or more of the following:
• fever at the time of evaluation (axillary temperature 37.5° C by digital thermometer)
• report of fever within the last two days
• profound anemia (conjunctival or palmar pallor)
• headache
• body aches
• abdominal pain
• decreased intake of food or fluids
• weakness
• Positive malaria smear for P. falciparum mono-infection
• Parasite density of 2,000-200,000/microliter or \< 10%
• Willingness to remain at the Health Centre under continuous observation until the resolution of the infection
• Parental consent for each participant, and child assent for children older than 5 years

You may not qualify if:

• Signs of severe malaria: One or more of the following:
• hemoglobin \< 5 g/dl
• parasitemia \> 10%
• prostration \* as indicated by inability to drink or breastfeed
• respiratory distress (deep Kussmaul respirations)
• bleeding
• recent seizures\*, coma\* or mental obtundation\* (Blantyre coma score less than 5)
• persistent vomiting\*
• Presence of a severe disease
• Presence of a febrile condition caused by diseases other than malaria
• Known allergy or history of adverse reaction to sulfadoxine/pyrimethamine (SP), sulfa drugs or chloroquine
• Chronic medication with an antifolate drug
• Enrollment in this clinical study in the past 28 days \*Each of these symptoms or signs is considered a "danger sign."

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Blantyre Malaria Project

Blantyre, Malawi

Location

Related Publications (1)

• Laufer MK, Thesing PC, Eddington ND, Masonga R, Dzinjalamala FK, Takala SL, Taylor TE, Plowe CV. Return of chloroquine antimalarial efficacy in Malawi. N Engl J Med. 2006 Nov 9;355(19):1959-66. doi: 10.1056/NEJMoa062032.

  PMID: 17093247 RESULT

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Chloroquine; fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 29, 2005
• First Posted: August 1, 2005
• Study Start: May 1, 2005
• Study Completion: December 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2007-03

Locations

MA (1)