Malaria,FalciparumMILK MalariaNCT05676645
Pharmacokinetics of Antimalarials in Breastfeeding Ugandan Mother-infant Pairs
An observational study of Malaria,Falciparum, run by University of Liverpool at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- Artemether-lumefantrine
- How many people
- 30 participants
- Where
- 1 siteUganda
- Study dates
- 20 Mar 2023to 25 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ugandan breastfeeding women requiring treatment for uncomplicated malaria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Drugs Used to Treat Uncomplicated Malaria in Breastfeeding Mother-infant Pairs: An Observational Pharmacokinetic Study
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.
Read the detailed description
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.
- Conditions
- Malaria,Falciparum
- Being tested
- Artemether-lumefantrine
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrineDrug
National policy recommendation for treatment of uncomplicated malaria in Uganda
| Study group | Role | What they receive |
|---|---|---|
| Participants | Breastfeeding women who have been prescribed (by a clinician independent from the study team) artemether-lumefantrine to treat uncomplicated malaria Receives: Drug: Artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24 of lumefantrine in maternal plasma and breastmilk
Maternal plasma exposure of lumefantrine
Measured: 0-24 hours after dose
AUC0-24 of lumefantrine breastmilk
Breastmilk exposure of lumefantrine
Measured: 0-24 hours after dose
Milk to plasma ratio of lumefantrine
Ratio of AUC in breastmilk to maternal plasma
Measured: 0-24 hours after dose
Secondary outcomes (9)
AUC desbutyl-lumefantrine plasma
Plasma exposure of active metabolite
Measured: 0-24 hours after dose
AUC desbutyl-lumefantrine breastmilk
Breastmilk exposure of active metabolite
Measured: 0-24 hours after dose
Milk to plasma ratio of desbutyl-lumefantrine
Ratio of breastmilk to maternal plasma of active metabolite
Measured: 0-24 hours after dose
Infant concentration lumefantrine
Infant lumefantrine exposure
Measured: 0-8 hours after maternal dose
Infant concentration desbutyl-lumefantrine
Infant exposure to active metabolite
Measured: 0-8 hours after maternal dose
Infant development
Infant assessment using Gross Motor Development Score (IGMDS)
Measured: 0-1 year old
Depression and anxiety in mothers
Patient Health Questionnaire (PHQ9)
Measured: 0-1 year postpartum
Depression and anxiety in mothers
General Anxiety Disorder (GAD7)
Measured: 0-1 year postpartum
Maternal beliefs about medicines
Beliefs about Medicines questionnaire (BMQ)
Measured: 0-1 year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start20 Mar 2023
- Primary completion10 Dec 2024
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria,FalciparumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Malawi-Liverpool-Wellcome Trust Clinical Research Programme
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676645
- Sponsor's protocol ID
- MILK Malaria
- Acronym
- MILK Malaria
- Status last verified
- Apr 2026
- First submitted
- 13 Dec 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data showing age, number of weeks postpartum and drug concentrations in plasma, breastmilk and infant plasma will be made available for future use following primary publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Drugs Used to Treat Uncomplicated Malaria in Breastfeeding Mother-infant Pairs: An Observational Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT05676645
- Acronym / sponsor ID
- MILK Malaria / MILK Malaria
- Conditions
- Malaria,Falciparum
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Makerere University, Malawi-Liverpool-Wellcome Trust Clinical Research Programme
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Drug: Artemether-lumefantrineBreastfeeding women who have been prescribed (by a clinician independent from the study team) artemether-lumefantrine to treat uncomplicated malaria |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ugandan breastfeeding women requiring treatment for uncomplicated malaria
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemether-lumefantrineNational policy recommendation for treatment of uncomplicated malaria in Uganda | Drug | Participants |
Primary outcome
AUC0-24 of lumefantrine in maternal plasma and breastmilk
Time frame: 0-24 hours after dose
Maternal plasma exposure of lumefantrine
AUC0-24 of lumefantrine breastmilk
Time frame: 0-24 hours after dose
Breastmilk exposure of lumefantrine
Milk to plasma ratio of lumefantrine
Time frame: 0-24 hours after dose
Ratio of AUC in breastmilk to maternal plasma
9 secondary outcomes
AUC desbutyl-lumefantrine plasma
Time frame: 0-24 hours after dose
AUC desbutyl-lumefantrine breastmilk
Time frame: 0-24 hours after dose
Milk to plasma ratio of desbutyl-lumefantrine
Time frame: 0-24 hours after dose
Infant concentration lumefantrine
Time frame: 0-8 hours after maternal dose
Infant concentration desbutyl-lumefantrine
Time frame: 0-8 hours after maternal dose
Infant development
Time frame: 0-1 year old
Depression and anxiety in mothers
Time frame: 0-1 year postpartum
Depression and anxiety in mothers
Time frame: 0-1 year postpartum
Maternal beliefs about medicines
Time frame: 0-1 year postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. Anonymised data showing age, number of weeks postpartum and drug concentrations in plasma, breastmilk and infant plasma will be made available for future use following primary publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria,Falciparum, run by University of Liverpool at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-24 of lumefantrine in maternal plasma and breastmilk (time frame: 0-24 hours after dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.