Pharmacokinetic Study of Multi-dose Chloroquine

Malaria Clinical Trial

Official title:

Pharmacokinetic Study of Multi-dose Chloroquine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814423
• Other study ID #: 2013-CQ
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2013
• Last updated: March 10, 2014
• Start date: April 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guinea-Bissau: Ministry of Health
• Study type: Interventional

Clinical Trial 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and any serious adverse events, drug concentrations and their relation to adverse events, the proportion of children withdrawn or lost to follow up, the cumulative PCR corrected and uncorrected success and failure rates on day 28 and the proportion of early, late clinical and late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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 9 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Chloroquine-base 50 mg

• Chloroquine-base 70 mg

Locations

Country	Name	City	State
Guinea-Bissau	Projecto de Saúde de Bandim	Bissau

Sponsors (1)

Lead Sponsor	Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Haemoglobin level	The haemoglobin level will be measured on the the specified days.	On day 0, 3 and 28.	No
Other	Blood pressure	Will be measures on day 1 at midday and on day 28.	On day 1 and day 28	Yes
Other	ECG		Will be measures on day 1 and on last treatment day.	Yes
Primary	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.	Yes
Secondary	Parasitemia	Blood smear for microscopy will be performed in the morning and evening on the days of treatment, and for the 50 mg group on day 3. During follow-uo weekly until day 28.	Twice a day dúring treatment and then weekly until day 28.	No