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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36731786

Enrollment

576

Registered

2005-10-26

Start date

2004-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated falciparum malaria Infections and Infestations Malaria

Interventions

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)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children (6-59 months), with uncomplicated falciparum malaria, =2000 Plasmodium falciparum, Burkinabe nationality

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Incidence of relevant adverse events 2. Incidence of treatment failures (TF)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Burkina Faso

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026