Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05676645
Study type Observational
Source University of Liverpool
Contact Catriona Waitt
Phone +256778288217
Email cwaitt@idi.co.ug
Status Recruiting
Phase
Start date March 20, 2023
Completion date December 2024

See also
  Status Clinical Trial Phase
Terminated NCT04130282 - VAC077: Safety and Immunogenicity of the Pfs25-IMX313/Matrix-M Vaccine Phase 1
Completed NCT04049916 - Pyronaridine-artesunate With Low Dose Primaquine for Preventing P. Falciparum Transmission Phase 2/Phase 3
Active, not recruiting NCT03814616 - Pyramax in Asymptomatic Carriers of P. Falciparum Monoinfections Phase 2
Active, not recruiting NCT04079621 - Short Course Radical Cure of P. Vivax Malaria in Nepal Phase 4
Completed NCT05135273 - Study of the Transmission-Blocking Vaccine Pfs230D1-EPA/Matrix-M Against Malaria in Adults in Mali Phase 1
Not yet recruiting NCT06083688 - Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi Phase 4
Recruiting NCT03511443 - Evaluation of the Performance of a hsRDT Versus cRDT in Reactive Case Detection of Malaria Infections N/A
Completed NCT05550909 - Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali Phase 2
Recruiting NCT05306067 - Plasmodium Falciparum Genomic Intelligence in Mozambique
Completed NCT05081089 - Gametocytocidal and Transmission-blocking Efficacy of PQ in Combination With AL and TQ in Combination With SPAQ in Mali Phase 2
Recruiting NCT05150808 - Vectron T500 (Broflanilide 50WP) for IRS in Tanzania Tanzania Phase 3
Recruiting NCT05757167 - Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics Phase 4
Completed NCT01992900 - A Pharmacokinetic/Pharmacodynamic Study of Eurartesim Dispersible Formulation in Infants With P.Falciparum Malaria Phase 2
Completed NCT04565184 - Effectiveness and Safety of Artesunate-Amodiaquine and Artemether-Lumefantrine for the Treatment of Malaria in Yaounde Phase 4
Completed NCT03896724 - Safety, Immunogenicity and Efficacy of R21 Matrix-M in 5-17 Month Old Children in Nanoro, Burkina Faso Phase 1/Phase 2
Completed NCT03454048 - Controlled Human Malaria Infection Model for Evaluation of Transmission-blocking Interventions - Study 2 N/A
Recruiting NCT04844905 - Adjunctive Ivermectin Mass Drug Administration for Malaria Control Phase 3
Completed NCT03138096 - Safety and Protective Efficacy of Pb(PfCS@UIS4) Phase 1/Phase 2
Recruiting NCT04271306 - Safety, Immunogenicity and ex Vivo Efficacy of Pfs25-IMX313/Matrix-M in Healthy Volunteers in Bagamoyo, Tanzania. Phase 1
Recruiting NCT05058885 - Plasmodium Vivax Among Duffy Negative Population in Cameroon.