Efficacy, Effect on Gametocytes and Tolerability of the Addition of Artesunate to Amodiaquine in Colombia

• Sponsor: Centro Internacional de Entrenamiento e Investigaciones Médicas (Other)
• Overall Status: Completed
• CT.gov ID: NCT00378625
• Collaborator: World Health Organization (Other), Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) (Other)
• Enrollment: 360
• Location: 1
• Duration (Months): 71
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in

Colombia. The benefit will be assessed in terms of:

• Efficacy

• Tolerability

• Time of fever clearance

• Time of parasite clearance

• Proportion of gametocyte carriers

Condition or Disease	Intervention/Treatment	Phase
Malaria,Falciparum; Malaria; Antimalarials	Drug: Artesunate	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Official Title: Randomised, Double Blind Clinical Trial of the Efficacy, Effect on Gametocytes and Tolerability of Amodiaquine Vs Amodiaquine Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Quibdo, Colombia
• Study Start Date: Apr 1, 2000
• Study Completion Date: Mar 1, 2006

Outcome Measures

Primary Outcome Measures

1. treatment failures []

2. adverse events []

3. gametocyte carriage []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. pure P. falciparum infection

2. parasitaemia >500 and <50,000 asexual parasites/μL (subsequently the lower limit was modified to >250 asexual parasites/μL)

3. age between 1 and 65 years old

4. availability to return for follow-up

Exclusion Criteria:

1. Pregnancy

2. history of allergy to the study drugs

3. history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week

4. have a medical history of untreated hypertension or chronic heart, kidney or liver disease

5. present any danger signs of severe malaria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Ismael Roldan and Centro de Salud San Vicente	Quibdo	Choco	Colombia	00

Sponsors and Collaborators

• Centro Internacional de Entrenamiento e Investigaciones Médicas
• World Health Organization
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Investigators

• Principal Investigator: Lyda Osorio, MD PhD, Centro Internacional de Entrenamiento e Investigaciones Médicas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00378625
• Other Study ID Numbers: A00096/990954; 2229-04-10380
• First Posted: Sep 20, 2006
• Last Update Posted: Sep 20, 2006
• Last Verified: Sep 1, 2006

• Additional relevant MeSH terms: Malaria; Malaria, Falciparum; Artesunate

Study Results

No Results Posted as of Sep 20, 2006