Dose finding for a safe and efficacious combination of chloroquine (CQ) and methylene blue in the treatment of uncomplicated falciparum malaria in young children of Burkina Faso

ISRCTN ISRCTN36731786
DOI https://doi.org/10.1186/ISRCTN36731786
Secondary identifying numbers BlueCQ3
Submission date
24/05/2005
Registration date
26/10/2005
Last edited
31/08/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Olaf Müller
Scientific

Department of Tropical Hygiene and Public Health
University of Heidelberg
Heidelberg
D-69120
Germany

+49 6221 56 5035
Olaf.Mueller@urz.uni-heidelberg.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymBlueCQ3
Study objectivesH_0 (safety): Probability of a relevant adverse event greater or equal to 10%
H_0 (efficacy): Probability of a treatment failure (TF) greater or equal to 15%
(used as criteria to proceed with the next higher dosage level)
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUncomplicated falciparum malaria
InterventionArm A (N = 288): Standard CQ + Methylene blue twice daily (3 consecutive dose levels)
Arm B (N = 288): Standard CQ + Methylene blue four times daily (3 consecutive dose levels)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Chloroquine (CQ) and methylene blue
Primary outcome measure1. Incidence of relevant adverse events
2. Incidence of treatment failures (TF)
Secondary outcome measures1. Incidence of early treatment failure (ETF)
2. Incidence of late clinical failures (LCF)
3. Incidence of late parasitological failures (LPF)
4. Fever clearance time
5. Parasite clearance time
6. Change in haemoglobin after 4 (or 7) and 14 days compared to baseline
7. Incidence of observed and self-reported non-serious adverse events over the 14 days observation period
8. Whole blood CQ and Methylene blue kinetics (mean area under the concentration–time curve [AUC], C[max], T[max], elimination half life)
9. Monitoring of concomitant drug intake
10. G6PD assessment based on PCR
Overall study start date01/07/2004
Completion date31/10/2004

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit59 Months
SexBoth
Target number of participants576
Key inclusion criteriaChildren (6-59 months), with uncomplicated falciparum malaria, ≥2000 Plasmodium falciparum, Burkinabe nationality
Key exclusion criteria1. Complicated or severe malaria
2. Hospitalised before for the same trial
3. Any apparent significant disease other than malaria
4. Hyperparasitaemia (>100,000/µl)
5. Patient is included in another trial
Date of first enrolment01/07/2004
Date of final enrolment31/10/2004

Locations

Countries of recruitment

  • Burkina Faso
  • Germany

Study participating centre

Department of Tropical Hygiene and Public Health
Heidelberg
D-69120
Germany

Sponsor information

DSM Fine Chemicals (Austria)
Industry

c/o Dr. Wolfgang Schiek
St. Peter-Str. 25
PO Box 933
Linz
A-4021
Austria

+43 732 6916 2150
wolfgang.schiek@dsm.com
ROR logo https://ror.org/01j7tpx52

Funders

Funder type

Industry

DSM Fine Chemicals, Dream Award (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 08/10/2006 Yes No
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