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

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Information provided by:
Centro Internacional de Entrenamiento e Investigaciones Médicas
ClinicalTrials.gov Identifier:
NCT00378625
First received: September 18, 2006
Last updated: September 19, 2006
Last verified: September 2006
  Purpose

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 Intervention Phase
Malaria,Falciparum
Malaria
Antimalarials
Drug: Artesunate
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Centro Internacional de Entrenamiento e Investigaciones Médicas:

Primary Outcome Measures:
  • treatment failures
  • adverse events
  • gametocyte carriage

Estimated Enrollment: 360
Study Start Date: April 2000
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   1 Year to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378625

Locations
Colombia
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00378625     History of Changes
Other Study ID Numbers: A00096/990954, 2229-04-10380
Study First Received: September 18, 2006
Last Updated: September 19, 2006
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Parasitic Diseases
Protozoan Infections
Amodiaquine
Artesunate
Amebicides
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014