Condition category
Infections and Infestations
Date applied
24/05/2005
Date assigned
26/10/2005
Last edited
31/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Olaf Müller

ORCID ID

Contact details

Department of Tropical Hygiene and Public Health
University of Heidelberg
Heidelberg
D-69120
Germany
+49 6221 56 5035
Olaf.Mueller@urz.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BlueCQ3

Study information

Scientific title

Acronym

BlueCQ3

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Chloroquine (CQ) and methylene blue

Primary outcome measures

1. Incidence of relevant adverse events
2. Incidence of treatment failures (TF)

Secondary outcome measures

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 concentration–time curve [AUC], C[max], T[max], elimination half life)
9. Monitoring of concomitant drug intake
10. G6PD assessment based on PCR

Overall trial start date

01/07/2004

Overall trial end date

31/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Children (6-59 months), with uncomplicated falciparum malaria, ≥2000 Plasmodium falciparum, Burkinabe nationality

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

576

Participant 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

Recruitment start date

01/07/2004

Recruitment end date

31/10/2004

Locations

Countries of recruitment

Burkina Faso

Trial participating centre

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

Sponsor information

Organisation

DSM Fine Chemicals (Austria)

Sponsor details

c/o Dr. Wolfgang Schiek
St. Peter-Str. 25
PO Box 933
Linz
A-4021
Austria
+43 732 6916 2150
wolfgang.schiek@dsm.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

DSM Fine Chemicals, Dream Award (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17026773

Publication citations

  1. Results

    Meissner PE, Mandi G, Coulibaly B, Witte S, Tapsoba T, Mansmann U, Rengelshausen J, Schiek W, Jahn A, Walter-Sack I, Mikus G, Burhenne J, Riedel KD, Schirmer RH, Kouyaté B, Müller O, Methylene blue for malaria in Africa: results from a dose-finding study in combination with chloroquine., Malar. J., 2006, 5, 84, doi: 10.1186/1475-2875-5-84.

Additional files

Editorial Notes