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OpenTrials
Completed

NCT Number: NCT01378286

Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax Malaria

Primary Objective:

- To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine

Secondary Objectives:

* To assess the non inferiority on the same way as the main criteria: * at Day 28 before corrected cure rate * at Day 14 and Day 42 before and after corrected cure rate * To compare the two groups of treatment in terms of: * Efficacy:

* Proportion of aparasitaemic patients at 24, 48 an 72 hours * Proportion of afebrile patients at 24, 48 and 72 hours * Percentage of gametocyte carriers during follow-up * Evolution of the mean of gametocytes during the 42 days of follow-up * Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28 * Clinical and biological tolerability:

* Proportion of any adverse event * Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins) * ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Administrative office

São Paulo, Brazil

About this study

Each patient will be followed for a period of 42 days

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults and children over 6 months old and bodyweight > 5 kg
  • Able to be treated by oral route
  • Axillary temperature ≥ 37,5 C or history of fever during the previous 2 days
  • Symptomatic biologically confirmed Plasmodium vivax mono-infection, with parasitemia from 250 to 100000 parasites /µl of blood
  • Written informed consent of the patients and for children written informed consent of the parents/legal representative for children. Children able to understand the objectives and the risks of the study will sign an assent form.

Exclusion criteria

  • Known project of leaving the investigator site area during the follow-up period (42 days)
  • Hypersensitivity to one of the investigational medicinal products or to any of the excipients
  • Intake of an antimalarial treatment in the previous 30 days
  • History of hepatic and (or) haematological impairment during treatment with amodiaquine
  • Blurred vision suggesting a retinopathy
  • Presence of at least one danger sign of malaria
  • Pregnant or breast-feeding women
  • Women with childbearing potential not willing to use an effective contraceptive method(s) for the duration of the study
  • Known severe concomitant or underlying disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Artesunate + Amodiaquine

Drug

Pharmaceutical form:

Route of administration:

Chloroquine

Drug

Pharmaceutical form:tablet Route of administration: oral

Primary outcomes

  1. Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction

    Time frame: 28 days

Secondary outcomes

  1. Assessment of clinical and parasitological efficacy based on temperature and parasitemia before and after PCR correction at D14 and D42 and before PCR correction at D28

    Time frame: up to a maximum of 42 days

  2. Number of patients without parasite

    Time frame: up to a maximum of 42 days

  3. Number of patients without fever

    Time frame: up to a maximum of 42 days

  4. Number of patients with gametocytes

    Time frame: up to a maximum of 42 days

  5. Change from baseline in Haemoglobin levels

    Time frame: Day 7, Day 28

  6. Incidence and severity of adverse events collected

    Time frame: up to a maximum of 42 days

  7. ECG (QTc) changes in patients group aged >= 10 years from baseline

    Time frame: Day 3, Day 28

  8. Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline

    Time frame: up to a maximum of 42 days

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomised Comparative Study to Assess the Efficacy and Tolerability of Blood Schizonticidal Treatments With Artesunate Amodiaquine Winthrop® / Coarsucam (ASAQ) Versus Chloroquine (CQ) for Uncomplicated Plasmodium Vivax Monoinfection Malaria

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 22, 2011
Registry last updated
Jul 18, 2013

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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