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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378625
• Other study ID #: A00096/990954
• Secondary ID: 2229-04-10380
• Status: Completed
• Phase: Phase 3
• First received: September 18, 2006
• Last updated: September 19, 2006
• Start date: April 2000
• Est. completion date: March 2006

Study information

• Verified date: September 2006
• Source: Centro Internacional de Entrenamiento e Investigaciones Médicas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Antimalarials
• Malaria
• Malaria, Falciparum
• Malaria,Falciparum

Intervention

Drug:
• Artesunate

Locations

Country	Name	City	State
Colombia	Hospital Ismael Roldan and Centro de Salud San Vicente	Quibdo	Choco

Sponsors (3)

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

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment failures
Primary	adverse events
Primary	gametocyte carriage