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Tafenoquine Drug Levels in Small Children

ConditionsPlasmodium Vivax MalariaVivax Malaria
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age28+
SponsorUniversity of Oxford

About this trial

This study is an open label, single arm, pharmacokinetic trial. A total of 20 participants (children ≤12kg and \>28 days old) will be enrolled. Enrollment will be competitive between Thailand and Vietnam study sites (each site will enroll as many patients that are eligible until the sample size is reached). Tafenoquine will be given concomitantly with the schizonticidal agent, chloroquine, on the day of enrolment. The participant will be admitted to hospital for observation and until the malaria smear is negative for asexual parasites on 2 consecutive days or until the schizonticidal treatment is completed, which will be approximately 3-7 days. All treatment doses will be supervised. Follow up will continue on days 7, 14, 21, and 28 then every month until month 4. Parent/guardian of participants will be instructed to follow up in between visits if participants are feeling unwell. Participants who are lost to follow up (any missed visit), who require drug re-administration after vomiting, or where at least 3 pharmacokinetic samples are not successfully drawn, will be replaced. Participants being replaced will continue in the study for safety assessments and to ensure the treatment of recurrences. The total blood drawn for this study will be 3.76 mL if the participant has no recurrences.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

P. vivax mono-infection as diagnosed by RDT or microscopy

Quantitative G6PD activity ≥70%

Age >28 days old and weight ≤12kg

The parent/guardian can understand the study instructions and provide written informed consent

Disqualifiers

Hb < 8 g/dL

Severe malaria

Blood transfusion in the last 3 months

Any previous history of severe anaemia or haemolysis

Trial design

Design model

Single group

Treatments tested in this trial

  • Chloroquine

    Drug

    Oral chloroquine tablets (250 mg). Total dose of 25 mg/kg base divided over 3 days (Days 0, 1, and 2).

  • Tafenoquine

    Drug

    Single oral dose administered according to body weight: 25 mg for \<5 kg; 50 mg for ≥5 kg to \<10 kg; 100 mg for ≥10 kg to 12 kg.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Tafenoquine Plus ChloroquineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Tafenoquine blood concentration-time curve area under the curve from time zero to infinity (AUC[0-∞])

The area under the tafenoquine concentration-time curve from time zero to infinity (AUC\[0-∞\]) will be estimated from the concentration-time data.

Time frame
days 1, 7, 28 and month 4
2

Maximum observed tafenoquine blood concentration (Cmax)

Maximum observed blood concentration (Cmax) will be estimated from the concentration-time data.

Time frame
days 1, 7, 28 and month 4
3

Terminal elimination half-life of tafenoquine (t½)

Terminal elimination half-life (t½) will be estimated from the concentration-time data.

Time frame
days 1, 7, 28 and month 4

Secondary outcomes

1

Number of adverse events and serious adverse events

The number of treatment-emergent adverse events and serious adverse events reported by caregivers, observed by study staff, or identified through clinical assessments will be recorded from treatment initiation through Month 4.

Time frame
up to month 4
2

Methaemoglobin levels measured by oximetry

Methaemoglobin levels will be measured by oximetry on Day 7 to assess the hematologic safety profile of tafenoquine treatment.

Time frame
day 7
3

CYP2D6 genotype and associated phenotype as defined by the Clinical Pharmacogenetics Implementation Consortium (CPIC)

CYP2D6 genotype will be determined and translated into predicted metabolizer phenotype according to Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines to evaluate genetic variation in drug metabolism.

Time frame
up to month 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oxford

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: