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Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso (ACTE)

Primary Purpose

Uncomplicated P. Falciparum Malaria in Children

Status
Completed
Phase
Phase 4
Locations
Burkina Faso
Study Type
Interventional
Intervention
Artesunate-amodiaquine
Artemether-lumefantrine
Sponsored by
Centre Muraz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncomplicated P. Falciparum Malaria in Children focused on measuring Uncomplicated malaria

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Weight > 5 kg;
  • Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 parasites /µl;
  • Fever (axillary temperature ≥37.5 °C) or history of fever in the preceding 24 hours;
  • Haemoglobin value above 5.0 g/dl;
  • Absence of febrile conditions caused by diseases other than malaria.

Exclusion Criteria:

  • Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;
  • Signs of severe malaria (WHO 2000);
  • Mixed malaria infection;
  • Severe malnutrition;
  • Other underlying diseases (cardiac, renal, hepatic diseases);
  • History of allergy to study drugs;

Sites / Locations

  • Nanoro
  • Nanoro
  • IRSS-DRO/Centre Muraz
  • Tinto Halidou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Artemether -lumefantrine

Artesunate-amodiaquine

Arm Description

Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso

Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso

Outcomes

Primary Outcome Measures

Polymerase chain reaction (PCR) adjusted treatment failure

Secondary Outcome Measures

Treatment failure up to day 42 (PCR adjusted and unadjusted)
Gametocytes (prevalence and density)
Hb changes

Full Information

First Posted
November 20, 2009
Last Updated
July 29, 2015
Sponsor
Centre Muraz
Collaborators
Institute of Tropical Medicine, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT01017770
Brief Title
Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso
Acronym
ACTE
Official Title
Artemether-lumefantrine Vs Co-formulated Amodiaquine + Artesunate for the Treatment of Uncomplicated Falciparum Malaria: a Randomized Open-label Trial to Evaluate the Effectiveness of the Burkina Faso New Drug Policy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Muraz
Collaborators
Institute of Tropical Medicine, Belgium

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated P. Falciparum Malaria in Children
Keywords
Uncomplicated malaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Artemether -lumefantrine
Arm Type
Experimental
Arm Description
Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
Arm Title
Artesunate-amodiaquine
Arm Type
Experimental
Arm Description
Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso
Intervention Type
Drug
Intervention Name(s)
Artesunate-amodiaquine
Other Intervention Name(s)
ASAQ, Coarsucam
Intervention Description
Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)
Intervention Type
Drug
Intervention Name(s)
Artemether-lumefantrine
Other Intervention Name(s)
AL, Coartem(R), Riamet(R)
Intervention Description
Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing > 35 kg.
Primary Outcome Measure Information:
Title
Polymerase chain reaction (PCR) adjusted treatment failure
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Treatment failure up to day 42 (PCR adjusted and unadjusted)
Time Frame
Day 42
Title
Gametocytes (prevalence and density)
Time Frame
At day 7, 14, 21, 28, 35 and 42 days after treatment
Title
Hb changes
Time Frame
Day 35

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Weight > 5 kg; Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 parasites /µl; Fever (axillary temperature ≥37.5 °C) or history of fever in the preceding 24 hours; Haemoglobin value above 5.0 g/dl; Absence of febrile conditions caused by diseases other than malaria. Exclusion Criteria: Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand; Signs of severe malaria (WHO 2000); Mixed malaria infection; Severe malnutrition; Other underlying diseases (cardiac, renal, hepatic diseases); History of allergy to study drugs;
Facility Information:
Facility Name
Nanoro
City
Nanoro
State/Province
Boulkiemdé
ZIP/Postal Code
115
Country
Burkina Faso
Facility Name
Nanoro
City
Nanoro
State/Province
Boulkiemdé
Country
Burkina Faso
Facility Name
IRSS-DRO/Centre Muraz
City
Bobo-Dioulasso
State/Province
Bp 545
ZIP/Postal Code
01
Country
Burkina Faso
Facility Name
Tinto Halidou
City
Bobo-Dioulasso
State/Province
Houet
ZIP/Postal Code
01
Country
Burkina Faso

12. IPD Sharing Statement

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Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso

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