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NCT Number: NCT05676645

Pharmacokinetics of Antimalarials in Breastfeeding Ugandan Mother-infant Pairs

Lactating women requiring treatment for uncomplicated malaria will be identified and invited for sampling. The decision to treat them with first-line treatment will have been made by the clinician, not by a member of the study team. The study team will not make any adjustments to the prescribed treatment. Artemether-lumefantrine comprises six doses of medication, with the initial two doses given 8 hours apart on Day 1, and dosing 12-hourly on Day 2 and Day 3. Intensive pharmacokinetic sampling will be undertaken after Dose 5, as indicated in the schema under Section 5: plasma and breastmilk samples will be obtained pre-dose and at 2, 4, 6, 8 hours after dose. In addition, sparse sampling will be undertaken on either of these occasions; at pre-dose and between 1 to 6 hours after the first dose; a trough (pre-dose) sample after the Dose 3 or Dose 4 and lastly at 5, 7, and up to 14-days after the first dose. A heelprick sample will also be obtained from the breastfed infants at maternal trough (prior to maternal dose) and at a random timepoint (once per infant) over the 8-hour pharmacokinetic sampling visit to characterize concentrations of these drugs over an 8-hour dosing interval. In addition, a single heelprick sample will be obtained from the infant whenever the mother returns after treatment for the late sampling time points (5, 7, and 14 days post the first dose). Due to the long half-life of lumefantrine of approximately 6 days plasma sampling will be performed up to day 14 to characterise the terminal elimination of the drug. Concentrations of total plasma and breastmilk lumefantrine and desbutyl-lumefantrine will be determined.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Malaria,Falciparum Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

14 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Infectious Diseases Institute

Kampala, 22418, Uganda

About this study

The endpoints of this study relate to the amount of antimalarial drug present in maternal blood, breastmilk and infant blood. The study is not powered for antimalarial efficacy, and therefore formal assessment of parasitological clearance is not required. The participants will be followed up until 30-40 days after completion of antimalarial therapy, and if recurrent symptoms occur, management will be as clinically indicated. Details regarding further clinical investigations and management required by either mother or infant during the follow-up period will be recorded on the CRF.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
  • Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Woman is aged 18 years or older, and mothers between the age of 14-17, who are considered emancipated minors.
  • Receiving treatment for uncomplicated malaria
  • Breastfeeding at enrolment

Exclusion criteria

  • Severe maternal or infant illness which in the opinion of the patient's clinician would interfere with her participation in the study
  • Breastfed infant is aged over 12 months
  • Partner objection to participate in the study
  • Maternal objection to infant participation

Treatment and study plan

Artemether-lumefantrine

Drug

National policy recommendation for treatment of uncomplicated malaria in Uganda

Primary outcomes

  1. AUC0-24 of lumefantrine in maternal plasma and breastmilk

    Time frame: 0-24 hours after dose

    Maternal plasma exposure of lumefantrine

  2. AUC0-24 of lumefantrine breastmilk

    Time frame: 0-24 hours after dose

    Breastmilk exposure of lumefantrine

  3. Milk to plasma ratio of lumefantrine

    Time frame: 0-24 hours after dose

    Ratio of AUC in breastmilk to maternal plasma

Secondary outcomes

  1. AUC desbutyl-lumefantrine plasma

    Time frame: 0-24 hours after dose

    Plasma exposure of active metabolite

  2. AUC desbutyl-lumefantrine breastmilk

    Time frame: 0-24 hours after dose

    Breastmilk exposure of active metabolite

  3. Milk to plasma ratio of desbutyl-lumefantrine

    Time frame: 0-24 hours after dose

    Ratio of breastmilk to maternal plasma of active metabolite

  4. Infant concentration lumefantrine

    Time frame: 0-8 hours after maternal dose

    Infant lumefantrine exposure

  5. Infant concentration desbutyl-lumefantrine

    Time frame: 0-8 hours after maternal dose

    Infant exposure to active metabolite

  6. Infant development

    Time frame: 0-1 year old

    Infant assessment using Gross Motor Development Score (IGMDS)

  7. Depression and anxiety in mothers

    Time frame: 0-1 year postpartum

    Patient Health Questionnaire (PHQ9)

  8. Depression and anxiety in mothers

    Time frame: 0-1 year postpartum

    General Anxiety Disorder (GAD7)

  9. Maternal beliefs about medicines

    Time frame: 0-1 year postpartum

    Beliefs about Medicines questionnaire (BMQ)

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • Makerere University
  • Malawi-Liverpool-Wellcome Clinical Research Programme

Registry information

Official study title

Pharmacokinetics of Drugs Used to Treat Uncomplicated Malaria in Breastfeeding Mother-infant Pairs: An Observational Pharmacokinetic Study

Acronym: MILK Malaria

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jan 9, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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