Pharmacokinetic Study of Multi-dose Chloroquine
1 other identifier
interventional
30
1 country
1
Brief Summary
Chloroquine (CQ) remains an alternative cheap, safe and widely available drug. Our previous research has shown that double (50 mg/kg) standard dose CQ given in split doses had a 95% efficacy and was well tolerated and safe. Still, safety could be an issue when the dose of CQ is increased. Severe adverse events are caused by high peak concentrations of CQ. Using split doses of CQ avoids high peak concentrations enabling the safe administration of high doses, however, pharmacokinetic data are lacking. Children included in the study will be given 50 mg/kg as split doses over 3 days or 70 mg/kg as split doses over 5 days. Treatment will be observed. Drug concentrations and adverse events will be monitored. On day 1, children and their mother/guardian will be requested to stay at the health centre between 9 am and 6 pm. Fifteen children aged 2-10 years with uncomplicated P. falciparum malaria and fulfilling the inclusion criteria will be recruited into each study arm. Following the end of treatment, the children will be seen on the morning of day 7, 14, 21 and 28. Any child wishing to withdraw during the treatment phase and any child with reparasitaemia during the follow up will be given rescue treatment with arthemeter-lumefantrine or quinine according to treatment guidelines in Guinea-Bissau. Final analysis will include a description of included children, proportions of adverse events and any serious adverse events, drug concentrations and their relation to adverse events, the proportion of children withdrawn or lost to follow up, the cumulative PCR corrected and uncorrected success and failure rates on day 28 and the proportion of early, late clinical and late parasitological treatment failures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2013
CompletedFirst Posted
Study publicly available on registry
March 20, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMarch 11, 2014
March 1, 2014
10 months
March 16, 2013
March 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chloroquine serum concentration
Filterpaper blood samples will be collected in the morning and evening on the days of treatment. On day 1 hourly during daytime.
Twice daily during treatment, on day 1 an additional 8 measurements.
Secondary Outcomes (1)
Parasitemia
Twice a day dúring treatment and then weekly until day 28.
Other Outcomes (3)
Haemoglobin level
On day 0, 3 and 28.
Blood pressure
On day 1 and day 28
ECG
Will be measures on day 1 and on last treatment day.
Study Arms (2)
Chloroquine-base 50 mg
EXPERIMENTALChloroquine-base 10 mg/kg twice a day for 2 days and 5 mg/kg twice a day for another day.
Chloroquine-base 70 mg
ACTIVE COMPARATORChloroquine-base 10 mg/kg twice a day for 2 days and 5 mg/kg twice a day for another 3 days.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 2 years and \< 10 years.
- Mono-infection with P. falciparum detected by microscopy. Parasitemia of 1.000-100.000/µl asexual forms.
- Axillary temperature ≥ 37.5 ˚C or a history of fever within 24 hours.
- Ability to swallow oral medication.
- Ability and willingness to comply with the study protocol.
- Informed consent from a parent or guardian
You may not qualify if:
- Signs or symptoms of severe malaria.
- Presence of general danger signs in children under 5.
- Persistent vomiting.
- Presence of severe malnutrition.
- Any evidence of chronic disease or acute infection other than malaria.
- Regular medication which may interfere with antimalarial pharmacokinetics.
- History of hypersensitivity reactions or contraindications to chloroquine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Projecto de Saúde de Bandim
Bissau, 1004, Guinea-Bissau
Related Publications (1)
Ursing J, Rombo L, Eksborg S, Larson L, Bruvoll A, Tarning J, Rodrigues A, Kofoed PE. High-Dose Chloroquine for Uncomplicated Plasmodium falciparum Malaria Is Well Tolerated and Causes Similar QT Interval Prolongation as Standard-Dose Chloroquine in Children. Antimicrob Agents Chemother. 2020 Feb 21;64(3):e01846-19. doi: 10.1128/AAC.01846-19. Print 2020 Feb 21.
PMID: 31907183DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Poul-Erik Kofoed, Ph.d
Bandim Health Project
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2013
First Posted
March 20, 2013
Study Start
April 1, 2013
Primary Completion
February 1, 2014
Study Completion
March 1, 2014
Last Updated
March 11, 2014
Record last verified: 2014-03