NCT00378625

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2006

Completed
Last Updated

September 20, 2006

Status Verified

September 1, 2006

First QC Date

September 18, 2006

Last Update Submit

September 19, 2006

Conditions

Malaria,FalciparumMalariaAntimalarials

Outcome Measures

Primary Outcomes (3)

  • treatment failures

  • adverse events

  • gametocyte carriage

Interventions

ArtesunateDRUG

Eligibility Criteria

Age1 Year - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Ismael Roldan and Centro de Salud San Vicente

Quibdó, Departamento del Chocó, 00, Colombia

Location

MeSH Terms

Conditions

Malaria, FalciparumMalaria

Interventions

Artesunate

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Lyda Osorio, MD PhD

    Centro Internacional de Entrenamiento e Investigaciones Médicas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2006

First Posted

September 20, 2006

Study Start

April 1, 2000

Study Completion

March 1, 2006

Last Updated

September 20, 2006

Record last verified: 2006-09

Locations

CO(1)