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Completed

NCT Number: NCT00378625

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

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

Completed

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Key information

Conditions

Malaria,Falciparum Antimalarials Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

1 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Ismael Roldan and Centro de Salud San Vicente

Quibdó, Departamento del Chocó, 00, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pure P. falciparum infection
  • parasitaemia >500 and <50,000 asexual parasites/μL (subsequently the lower limit was modified to >250 asexual parasites/μL)
  • age between 1 and 65 years old
  • availability to return for follow-up

Exclusion criteria

  • Pregnancy
  • history of allergy to the study drugs
  • history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week
  • have a medical history of untreated hypertension or chronic heart, kidney or liver disease
  • present any danger signs of severe malaria.

Treatment and study plan

Artesunate

Drug

Primary outcomes

  1. treatment failures

  2. adverse events

  3. gametocyte carriage

Sponsors and collaborators

Lead sponsor

Centro Internacional de Entrenamiento e Investigaciones Médicas

Other

Collaborators

  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
  • World Health Organization

Registry information

Official study 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

Important dates

Study start
2000
Study completion
2006
First posted
Sep 20, 2006
Registry last updated
Sep 20, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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