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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2006-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Malaria,Falciparum Malaria Antimalarials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Artesunate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Lyda Osorio, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Internacional de Entrenamiento e Investigaciones Médicas

Locations

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Hospital Ismael Roldan and Centro de Salud San Vicente

Quibdó, Departamento del Chocó, Colombia

Site Status

Countries

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Colombia

Other Identifiers

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2229-04-10380

Identifier Type: -

Identifier Source: secondary_id

A00096/990954