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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00378625

Enrollment

360

Registered

2006-09-20

Start date

2000-04-30

Completion date

2006-03-31

Last updated

2006-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antimalarials, Malaria, Malaria,Falciparum

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

Interventions

DRUGArtesunate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

1 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
treatment failures	—
adverse events	—
gametocyte carriage	—

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026