NCT00545935

Brief Summary

The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

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

July 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed
Last Updated

February 3, 2009

Status Verified

February 1, 2009

First QC Date

October 16, 2007

Last Update Submit

February 2, 2009

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • Incidence of observed and self-reported non-serious adverse events over the 28 days observation period

    28 days

Secondary Outcomes (8)

  • Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)

    28 days

  • Early treatment failure (ETF) rate

    28 days

  • Late clinical failure (LCF) rate at D14 and D28

    28 days

  • Late parasitological failure (LPF) rate at D14 and D28

    28 days

  • Fever clearance time

    28 days

  • +3 more secondary outcomes

Study Arms (3)

1-Methylenblue-Amodiaquine

ACTIVE COMPARATOR
Drug: Methylenblue-Amodiaquine (MB-AQ)

2-Methylenblue-Artesunate

ACTIVE COMPARATOR
Drug: Methylenblue-Artesunate (MB-AS)

3-Artesunate-Amodiaquine

ACTIVE COMPARATOR
Drug: Artesunate-Amodiaquine (AS-AQ)

Interventions

Methylenblue-Amodiaquine (MB-AQ)DRUG

For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ

1-Methylenblue-Amodiaquine
Methylenblue-Artesunate (MB-AS)DRUG

3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days

2-Methylenblue-Artesunate
Artesunate-Amodiaquine (AS-AQ)DRUG

For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.

3-Artesunate-Amodiaquine

Eligibility Criteria

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

You may qualify if:

  • year (6-59 months) old children
  • uncomplicated malaria caused by P. falciparum
  • asexual parasites ≥ 2000/µ and ≤ 200000/µ
  • axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours
  • Burkinabe nationality
  • informed consent

You may not qualify if:

  • complicated or severe malaria
  • any apparent significant disease
  • anaemia (haematocrit \< 21%)
  • treated in the same trial before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Sante de Nouna

Nouna, Burkina Faso

Location

MeSH Terms

Conditions

Malaria

Interventions

amodiaquine, artesunate drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Olaf Mueller, Prof.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2007

First Posted

October 17, 2007

Study Start

July 1, 2007

Study Completion

October 1, 2007

Last Updated

February 3, 2009

Record last verified: 2009-02

Locations

BU(1)