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
Protocol serial number	BlueCQ3
Sponsor	DSM Fine Chemicals (Austria)
Funder	DSM Fine Chemicals, Dream Award (Netherlands)

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

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	BlueCQ3
Study objectives	H_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) studied	Uncomplicated falciparum malaria
Intervention	Arm 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 type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Chloroquine (CQ) and methylene blue
Primary outcome measure(s)	1. Incidence of relevant adverse events 2. Incidence of treatment failures (TF)
Key secondary outcome measure(s)	1. 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 concentrationtime curve [AUC], C[max], T[max], elimination half life) 9. Monitoring of concomitant drug intake 10. G6PD assessment based on PCR
Completion date	31/10/2004

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	59 Months
Sex	All
Target sample size at registration	576
Key inclusion criteria	Children (6-59 months), with uncomplicated falciparum malaria, ≥2000 Plasmodium falciparum, Burkinabe nationality
Key exclusion criteria	1. 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 enrolment	01/07/2004
Date of final enrolment	31/10/2004

Locations

Countries of recruitment

Burkina Faso
Germany

Study participating centre

Department of Tropical Hygiene and Public Health

Heidelberg
D-69120
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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