Healthy Lactating WomenPhase 4TBMNCT04984759
Tafenoquine and Primaquine in Colostrum and Breast Milk
A Phase 4 study testing Primaquine and Tafenoquine in people with Healthy Lactating Women, run by University of Oxford at 1 site in Thailand.
Trial summary
Each year almost a million infants are born small for gestational age due to malaria infection in pregnancy. These infants are at risk for stillbirth or neonatal death, and being born too small predisposes the survivors to increased metabolic diseases later in life. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Lactating Women
- What is being tested?
- Primaquine and Tafenoquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2023to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother
- Lactating women >= 16 years old who are breast feeding one child who fits the time window for the respective study arm
- Planning to breastfeed for the duration of the study
- Willingness and ability to comply with the study protocol for the duration of the study
- Willingness to delay pregnancy until the end of the period of drug exposure (14 days for PMQ and 90 days for TQ)
- Current pregnancy excluded by urine pregnancy test and ultrasound OR immediate postpartum status (≤2 months)
Show all 11Show fewer
- Can understand information about the study and provide consent
- Children
- Healthy children falling into the time window for the respective study arm
- ≤ 5 days for Arms 1 \& 3
- > 14 days for Arm 2
Who cannot join
- Mothers
- Known hypersensitivity to PMQ or TQ, defined as history of erythroderma/other severe cutaneous reaction, angioedema or anaphylaxis
- Known Glucose-6-phosphate-dehydrogenase (G6PD) deficiency in mother defined as G6PD activity <70% of normal male population median by spectrophotometry
- Presence of any condition which in the judgement of the investigator would place the participant at undue risk or interfere with the results of the study
- Alkaline phosphatase (ALT) > 2x the upper limit of normal (ULN)
- Pregnancy
Show all 19Show fewer
- Screening hematocrit (Hct) <33%
- Known history of severe jaundice in a previous child
- Known history of psychiatric illness or abnormal depression screening score
- Blood transfusion within the 3 months before screening
- Children
- Known hypersensitivity to primaquine or tafenoquine, defined as history of erythroderma/other severe cutaneous reaction, angioedema or anaphylaxis
- Known Glucose-6-phosphate-dehydrogenase (G6PD) deficiency in child defined as G6PD activity <70% of normal male population median by spectrophotometry in children
- Presence of any condition which in the judgement of the investigator would place the participant at undue risk or interfere with the results of the study
- Screening Hct <33%
- Estimated gestational age at birth < 38 weeks
- Blood transfusion within the 3 months before screening
- Evidence of birth asphyxia (5 min Apgar score <7)
- Moderate or severe jaundice as defined as total serum bilirubin above treatment line on day 1 (before maternal dose)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Shoklo Malaria Research Unit (SMRU)
Mae Sot, Changwat Tak, 63110
About this study
Official title: Breastfed Child Exposure to Tafenoquine and Primaquine During Treatment in Lactating Women: a Pharmacokinetic Study in Healthy Volunteers
Each year almost a million infants are born small for gestational age due to malaria infection in pregnancy. These infants are at risk for stillbirth or neonatal death, and being born too small predisposes the survivors to increased metabolic diseases later in life. Plasmodium vivax (PV) is the second most common malaria species globally. Its relapsing nature results in multiple episodes of PV in a single pregnancy, compounding growth restriction and stillbirth risk. Women with PV in one pregnancy may harbor dormant parasites (hypnozoites) in their liver the cause illness and poor fetal growth in a subsequent pregnancy.
Only radical cure with 8-aminoquinolines (8AQ)- primaquine (PMQ) or tafenoquine (TQ) - can eliminate hypnozoites, but these drugs are contraindicated in pregnancy. The postpartum period presents a key window of opportunity for giving radical cure to women of childbearing age with PV. Pharmacokinetic data is needed to support safe use of these drugs postpartum and World Health Organization has identified pharmacokinetic studies of 8AQ in lactation as a research priority.
Read more
Primaquine is excreted minimally in mature breast milk, at <1% of the weight-adjusted relative infant dose (RID). As the main adverse event associated with both 8AQ - hemolysis glucose-6-phosphate dehydrogenase (G6PD) deficient individuals - is dose-dependent and negligible at low doses, this finding strongly supports its safe use in later lactation. This study is needed to determine if primaquine can also be given safely in the early postpartum period. There is no published data on tafenoquine excretion in breastmilk, and this study would quantify safety throughout early and late lactation.
Drug safety studies in lactation are essential to ensure medications are not denied and unnecessary interruption of breastfeeding is avoided. Demonstration of safety of radical cure for breastfeeding women in the postpartum period would allow women with PV in pregnancy and lactation to receive 8AQ after delivery, preventing illnesses in the postpartum period and subsequent pregnancies. Improved uptake of radical cure through elimination of unnecessary contraindications supports malaria elimination and community health.
The main purpose of this study is to characterize the transfer of tafenoquine and primaquine in breast milk of mothers receiving radical cure doses of 8AQ throughout the different phases of lactation - colostrum, transitional milk, and mature milk - in order to determine the degree of infant exposure.
Read the detailed description
The study will take place at clinics of the Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit in Tak Province, Thailand. The clinics serve a population of migrant workers resident along the Thailand-Myanmar border. Non-pregnant breastfeeding women that access care at SMRU (postnatal care, outpatient, vaccine and routine baby care departments) will be invited to participate with their breastfed children.
All lactating women and their children will be G6PD phenotypically normal. Participants will be enrolled as follows; Arm 1: Primaquine mother-neonate pairs Arm 2: Tafenoquine mother-child pairs Arm 3: Tafenoquine mother-neonate pairs
Pharmacokinetic sampling plan:
- PMQ pharmacokinetic sampling (Mother/Neonate pairs - Arm 1):
- Mothers: Dense pharmacokinetic venous blood and breast milk sampling will be performed during day 1 and 14; one sample of blood and breast milk will collected at a single timepoint on days 3, 5 and 8.
- Neonate: One capillary blood sample will be collected on the same days as maternal sampling.
- TQ pharmacokinetic sampling (Mother/child pairs - Arms 2, and 3):
- Mothers: Dense pharmacokinetic venous blood and breast milk sampling will be performed during the first day after dosing, followed by one sample of blood and breast milk at a single time point on days 2, 3, 8, 15, 29, 43 and 75 (allowing a description of approximately 95% of the total drug exposure).
- Child: One capillary blood sample will be collected on the same days as maternal sampling.
Mothers and children will be closely monitored for safety throughout the 75 day follow up period including regular assessments of adverse events, Hb, Hct and MetHb levels. Pharmacokinetic drug measurements of primaquine, carboxyprimaquine and tafenoquine will be performed at the Department of Clinical Pharmacology, Mahidol-Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand. Drug concentrations will be quantified by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). Interim data review will be done by an external drug safety monitoring board (DSMB) before recruitment of Arm 3. The board will review safety data and any available PK data. If PK data is not yet available and there are safety concerns, recruitment in Arm 3 may be suspended until PK data from Arms 1 and 2 are available.
Study participants with any adverse events will be followed until the event has stabilized or resolved (unless the participant refuses such follow up care). Free care will be offered through SMRU clinics. For severe harm caused by study procedures following this protocol, Oxford University insurance will support additional health care beyond SMRU's capacity.
This study is funded by Thrasher Research Fund.
- Conditions
- Healthy Lactating Women
- Being tested
- Primaquine, Tafenoquine
- Keywords
- Healthy lactating women, Tafenoquine, Primaquine, Plasmodium Vivax, Pharmacokinetic
- Medical subject headings
- Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimaquineDrug
Also called Primaquine GPO®
Primaquine GPO® (Government Pharmaceutical Organization (GPO), Thailand) 0.5 mg/kg will be given once daily with food for 14 days. This is the dose recommended for radical cure of P. vivax in tropical areas with high rates of relapse, such as the study design setting. Doses will be directly supervised (DOT).
TafenoquineDrug
Also called Kodatef
Tafenoquine (Kodatef, Biocelect Pty Ltd.) 300 mg will be given as a directly observed single dose with food. This is the standard dose recommended globally for radical cure of P. vivax.
| Study group | Role | What they receive |
|---|---|---|
| Primaquine in colostrum and transitional milk (mother-neonate pairs) | Experimental | 12 women who are breast feeding neonates ≤5 days old will be recruited into the primaquine arm. They will receive primaquine 0.5 mg/kg daily for 14 days directly observed in the clinic. Receives: Drug: Primaquine |
| Tafenoquine in mature milk (mother-child pairs) | Experimental | 24 women who are breast feeding infants or young children > 14 days will be recruited into Arm 2. They will receive a single 300 mg dose of tafenoquine directly observed in the clinic. Investigators will begin with recruiting 2-4 women breastfeeding young children ≥12 months old. Receives: Drug: Tafenoquine |
| Tafenoquine in colostrum and transitional milk (mother-neonate pairs) | Experimental | 12 women who are breast feeding neonates ≤ 5 days old will be recruited into Arm 3. They will receive a single 300 mg dose of tafenoquine directly observed in the clinic. Receives: Drug: Tafenoquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the excretion of tafenoquine and primaquine (with its main metabolite, carboxyprimaquine) in colostrum, transitional milk and mature milk in order to determine the degree of infant exposure
End points: Area under the time-concentration curve (AUC) for 8-aminoquinolines in colostrum, transitional milk and mature milk.
Relative infant dose (RID) for 8-aminoquinolines calculated using AUCs for drug in maternal plasma and colostrum, transitional milk and mature milk.
Measured: Days 1-14 for primaquine, Days 1-75 for tafenoquine
Secondary outcomes (5)
To evaluate the pharmacokinetics (PK) of primaquine and tafenoquine in lactating women and their breastfed children at different time points following delivery.
End point: AUC of tafenoquine and primaquine for mother and child (if measurable concentrations found in child plasma).
Measured: Days 1-14 for primaquine, Days 1-75 for tafenoquine
To evaluate the pharmacokinetics (PK) of primaquine and tafenoquine in lactating women and their breastfed children at different time points following delivery.
End point: Time to maximum concentration (Tmax) of tafenoquine and primaquine for mother and child (if measurable concentrations found in child plasma).
Measured: Days 1-14 for primaquine, Days 1-75 for tafenoquine
To evaluate the pharmacokinetics (PK) of primaquine and tafenoquine in lactating women and their breastfed children at different time points following delivery.
End point: Maximum concentration reached (Cmax) of tafenoquine and primaquine for mother and child (if measurable concentrations found in child plasma).
Measured: Days 1-14 for primaquine, Days 1-75 for tafenoquine
To describe hematologic changes in mothers and breastfeed children during maternal ingestion of radical cure doses of 8-aminoquinolines.
End points: Changes in hemoglobin (Hb), hematocrit (Hct) and methemoglobin (MetHb) in mothers and children over the period of drug exposure.
Measured: Days 1-75
To assess adverse events of maternal radical cure doses of 8-aminoquinolines in mothers and their breastfeeding children.
End points: Number, severity and type of adverse events in mothers and children during the period of drug exposure.
Measured: Days 1-75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Jul 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: Local EC requested that the arms of study be submitted as separate protocols so they could respond to the different risk of each arm. In response investigators have withdrawn this protocol and begun separate submissions, starting with NCT06191458.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Lactating WomenStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Arms 1 and 2 will enroll first as preliminary data from Arms 1 and 2 is needed before Arm 3 can begin enrolment. All eligible and consenting women who are immediately postpartum will be enrolled in Arm 1 until it is completed. Arm 2 will enroll eligible women breastfeeding older infants and young children. If there are no safety concerns after 2-4 mother-child dyads have been enrolled in Arm 2, successively younger infants will be enrolled to a minimum of 14 days old. If there are no safety concerns with Arms 1 and 2, Arm 3 will begin enrolment.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Responsible party
- Sponsor
- Investigators
- Rose McGready, Ph.D, Principal investigator, Shoklo Malaria Research Unit (SMRU), PO Box 46, 68/30 Ban Toong Road, Mae Sot, Tak 63110
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984759
- Sponsor's protocol ID
- MAL21004
- Acronym
- TBM
- Status last verified
- Mar 2024
- First submitted
- 14 Jul 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be published in the open access medical literature with the identity of the participants protected. Criteria for authorship will follow international guidelines. Following completion of the study, the database will belong to the PI and key co-investigators. The database, including individual participant data, may be shared with researchers not directly involved with the study after the original research has been published and in accordance with SMRU and MORU data sharing policies. The results of the study will be shared with the local community.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfed Child Exposure to Tafenoquine and Primaquine During Treatment in Lactating Women: a Pharmacokinetic Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04984759
- Acronym / sponsor ID
- TBM / MAL21004
- Conditions
- Healthy Lactating Women
- Keywords
- Healthy lactating women, Tafenoquine, Primaquine, Plasmodium Vivax, Pharmacokinetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Local EC requested that the arms of study be submitted as separate protocols so they could respond to the different risk of each arm. In response investigators have withdrawn this protocol and begun separate submissions, starting with NCT06191458.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Aug 2021 (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.
Each year almost a million infants are born small for gestational age due to malaria infection in pregnancy. These infants are at risk for stillbirth or neonatal death, and being born too small predisposes the survivors to increased metabolic diseases later in life. Plasmodium vivax (PV) is the second most common malaria species globally. Its relapsing nature results in multiple episodes of PV in a single pregnancy, compounding growth restriction and stillbirth risk. Women with PV in one pregnancy may harbor dormant parasites (hypnozoites) in their liver the cause illness and poor fetal growth in a subsequent pregnancy.
Only radical cure with 8-aminoquinolines (8AQ)- primaquine (PMQ) or tafenoquine (TQ) - can eliminate hypnozoites, but these drugs are contraindicated in pregnancy. The postpartum period presents a key window of opportunity for giving radical cure to women of childbearing age with PV. Pharmacokinetic data is needed to support safe use of these drugs postpartum and World Health Organization has identified pharmacokinetic studies of 8AQ in lactation as a research priority.
Primaquine is excreted minimally in mature breast milk, at <1% of the weight-adjusted relative infant dose (RID). As the main adverse event associated with both 8AQ - hemolysis glucose-6-phosphate dehydrogenase (G6PD) deficient individuals - is dose-dependent and negligible at low doses, this finding strongly supports its safe use in later lactation. This study is needed to determine if primaquine can also be given safely in the early postpartum period. There is no published data on tafenoquine excretion in breastmilk, and this study would quantify safety throughout early and late lactation.
Drug safety studies in lactation are essential to ensure medications are not denied and unnecessary interruption of breastfeeding is avoided. Demonstration of safety of radical cure for breastfeeding women in the postpartum period would allow women with PV in pregnancy and lactation to receive 8AQ after delivery, preventing illnesses in the postpartum period and subsequent pregnancies. Improved uptake of radical cure through elimination of unnecessary contraindications supports malaria elimination and community health.
The main purpose of this study is to characterize the transfer of tafenoquine and primaquine in breast milk of mothers receiving radical cure doses of 8AQ throughout the different phases of lactation - colostrum, transitional milk, and mature milk - in order to determine the degree of infant exposure.
Detailed description
The study will take place at clinics of the Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit in Tak Province, Thailand. The clinics serve a population of migrant workers resident along the Thailand-Myanmar border. Non-pregnant breastfeeding women that access care at SMRU (postnatal care, outpatient, vaccine and routine baby care departments) will be invited to participate with their breastfed children.
All lactating women and their children will be G6PD phenotypically normal. Participants will be enrolled as follows; Arm 1: Primaquine mother-neonate pairs Arm 2: Tafenoquine mother-child pairs Arm 3: Tafenoquine mother-neonate pairs
Pharmacokinetic sampling plan:
- PMQ pharmacokinetic sampling (Mother/Neonate pairs - Arm 1):
- Mothers: Dense pharmacokinetic venous blood and breast milk sampling will be performed during day 1 and 14; one sample of blood and breast milk will collected at a single timepoint on days 3, 5 and 8.
- Neonate: One capillary blood sample will be collected on the same days as maternal sampling.
- TQ pharmacokinetic sampling (Mother/child pairs - Arms 2, and 3):
- Mothers: Dense pharmacokinetic venous blood and breast milk sampling will be performed during the first day after dosing, followed by one sample of blood and breast milk at a single time point on days 2, 3, 8, 15, 29, 43 and 75 (allowing a description of approximately 95% of the total drug exposure).
- Child: One capillary blood sample will be collected on the same days as maternal sampling.
Mothers and children will be closely monitored for safety throughout the 75 day follow up period including regular assessments of adverse events, Hb, Hct and MetHb levels. Pharmacokinetic drug measurements of primaquine, carboxyprimaquine and tafenoquine will be performed at the Department of Clinical Pharmacology, Mahidol-Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand. Drug concentrations will be quantified by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). Interim data review will be done by an external drug safety monitoring board (DSMB) before recruitment of Arm 3. The board will review safety data and any available PK data. If PK data is not yet available and there are safety concerns, recruitment in Arm 3 may be suspended until PK data from Arms 1 and 2 are available.
Study participants with any adverse events will be followed until the event has stabilized or resolved (unless the participant refuses such follow up care). Free care will be offered through SMRU clinics. For severe harm caused by study procedures following this protocol, Oxford University insurance will support additional health care beyond SMRU's capacity.
This study is funded by Thrasher Research Fund.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Arms 1 and 2 will enroll first as preliminary data from Arms 1 and 2 is needed before Arm 3 can begin enrolment. All eligible and consenting women who are immediately postpartum will be enrolled in Arm 1 until it is completed. Arm 2 will enroll eligible women breastfeeding older infants and young children. If there are no safety concerns after 2-4 mother-child dyads have been enrolled in Arm 2, successively younger infants will be enrolled to a minimum of 14 days old. If there are no safety concerns with Arms 1 and 2, Arm 3 will begin enrolment.
| Arm | Type | Receives |
|---|---|---|
| Primaquine in colostrum and transitional milk (mother-neonate pairs) | Experimental | Drug: Primaquine12 women who are breast feeding neonates ≤5 days old will be recruited into the primaquine arm. They will receive primaquine 0.5 mg/kg daily for 14 days directly observed in the clinic. |
| Tafenoquine in mature milk (mother-child pairs) | Experimental | Drug: Tafenoquine24 women who are breast feeding infants or young children > 14 days will be recruited into Arm 2. They will receive a single 300 mg dose of tafenoquine directly observed in the clinic. Investigators will begin with recruiting 2-4 women breastfeeding young children ≥12 months old. |
| Tafenoquine in colostrum and transitional milk (mother-neonate pairs) | Experimental | Drug: Tafenoquine12 women who are breast feeding neonates ≤ 5 days old will be recruited into Arm 3. They will receive a single 300 mg dose of tafenoquine directly observed in the clinic. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Mother
- Children
Key exclusion criteria (19 listed)
- Mothers
- Children
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 |
|---|---|---|
| PrimaquineAlso: Primaquine GPO®Primaquine GPO® (Government Pharmaceutical Organization (GPO), Thailand) 0.5 mg/kg will be given once daily with food for 14 days. This is the dose recommended for radical cure of P. vivax in tropical areas with high rates of relapse, such as the study design setting. Doses will be directly supervised (DOT). | Drug | Primaquine in colostrum and transitional milk (mother-neonate pairs) |
| TafenoquineAlso: KodatefTafenoquine (Kodatef, Biocelect Pty Ltd.) 300 mg will be given as a directly observed single dose with food. This is the standard dose recommended globally for radical cure of P. vivax. | Drug | Tafenoquine in colostrum and transitional milk (mother-neonate pairs), Tafenoquine in mature milk (mother-child pairs) |
Primary outcome
To characterize the excretion of tafenoquine and primaquine (with its main metabolite, carboxyprimaquine) in colostrum, transitional milk and mature milk in order to determine the degree of infant exposure
Time frame: Days 1-14 for primaquine, Days 1-75 for tafenoquine
End points: Area under the time-concentration curve (AUC) for 8-aminoquinolines in colostrum, transitional milk and mature milk. Relative infant dose (RID) for 8-aminoquinolines calculated using AUCs for drug in maternal plasma and colostrum, transitional milk and mature milk.
5 secondary outcomes
To evaluate the pharmacokinetics (PK) of primaquine and tafenoquine in lactating women and their breastfed children at different time points following delivery.
Time frame: Days 1-14 for primaquine, Days 1-75 for tafenoquine
To evaluate the pharmacokinetics (PK) of primaquine and tafenoquine in lactating women and their breastfed children at different time points following delivery.
Time frame: Days 1-14 for primaquine, Days 1-75 for tafenoquine
To evaluate the pharmacokinetics (PK) of primaquine and tafenoquine in lactating women and their breastfed children at different time points following delivery.
Time frame: Days 1-14 for primaquine, Days 1-75 for tafenoquine
To describe hematologic changes in mothers and breastfeed children during maternal ingestion of radical cure doses of 8-aminoquinolines.
Time frame: Days 1-75
To assess adverse events of maternal radical cure doses of 8-aminoquinolines in mothers and their breastfeeding children.
Time frame: Days 1-75
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Yes. All data will be published in the open access medical literature with the identity of the participants protected. Criteria for authorship will follow international guidelines. Following completion of the study, the database will belong to the PI and key co-investigators. The database, including individual participant data, may be shared with researchers not directly involved with the study after the original research has been published and in accordance with SMRU and MORU data sharing policies. The results of the study will be shared with the local community.
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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.
Rose McGready, Ph.D principal investigator
Shoklo Malaria Research Unit (SMRU), PO Box 46, 68/30 Ban Toong Road, Mae Sot, Tak 63110
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Primaquine and Tafenoquine in people with Healthy Lactating Women, run by University of Oxford at 1 site in Thailand.
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 11 inclusion and 19 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: withdrawn, as of the sponsor's last update on 4 Apr 2024. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To characterize the excretion of tafenoquine and primaquine (with its main metabolite, carboxyprimaquine) in colostrum, transitional milk and mature milk in order to determine the degree of infant exposure (time frame: Days 1-14 for primaquine, Days 1-75 for tafenoquine). 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 4 Apr 2024.