NCT01017770

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

4 active sites

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

September 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

November 20, 2009

Last Update Submit

July 29, 2015

Conditions

Uncomplicated P. Falciparum Malaria in Children

Keywords

Uncomplicated malaria

Outcome Measures

Primary Outcomes (1)

  • Polymerase chain reaction (PCR) adjusted treatment failure

    Day 28

Secondary Outcomes (3)

  • Treatment failure up to day 42 (PCR adjusted and unadjusted)

    Day 42

  • Gametocytes (prevalence and density)

    At day 7, 14, 21, 28, 35 and 42 days after treatment

  • Hb changes

    Day 35

Study Arms (2)

Artemether -lumefantrine

EXPERIMENTAL

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

Drug: Artemether-lumefantrine

Artesunate-amodiaquine

EXPERIMENTAL

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

Drug: Artesunate-amodiaquine

Interventions

Artesunate-amodiaquineDRUG

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)

Also known as: ASAQ, Coarsucam
Artesunate-amodiaquine
Artemether-lumefantrineDRUG

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.

Also known as: AL, Coartem(R), Riamet(R)
Artemether -lumefantrine

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Nanoro

Nanoro, Boulkiemdé, 115, Burkina Faso

Location

Nanoro

Nanoro, Boulkiemdé, Burkina Faso

Location

IRSS-DRO/Centre Muraz

Bobo-Dioulasso, Bp 545, 01, Burkina Faso

Location

Tinto Halidou

Bobo-Dioulasso, Houet, 01, Burkina Faso

Location

MeSH Terms

Interventions

amodiaquine, artesunate drug combinationArtemether, Lumefantrine Drug Combination

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD, PhD

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 23, 2009

Study Start

September 1, 2008

Primary Completion

January 1, 2010

Study Completion

August 1, 2010

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

BU(4)