Delivery of Malaria Chemoprevention in the Post-discharge Management of Children With Severe Anaemia in Malawi
PMC
Malaria Chemoprevention With Monthly Treatment With Dihydroartemisinin-Piperaquine for the Post-discharge Management of Severe Anaemia in Children Less Than 5 Years in Malawi
1 other identifier
interventional
375
1 country
1
Brief Summary
Background and rationale: Children hospitalised with severe anaemia in Africa are at high risk of readmission or death within 6 months after discharge. No strategy specifically addresses this post-discharge period. In Malawi, 3 months of post-discharge malaria chemoprevention (PMC) with monthly 3-day treatment courses of artemether-lumefantrine (AL) in children with severe malarial anaemia prevented 31% of deaths and readmissions. The effect was in addition to the effect of insecticide-treated bednets. There is now need to design and evaluate effective delivery mechanism for PMC within the health system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2016
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2016
CompletedStudy Start
First participant enrolled
March 24, 2016
CompletedFirst Posted
Study publicly available on registry
March 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 1, 2018
January 1, 2018
2.9 years
February 13, 2016
January 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of those with 100 % uptake of PMC drugs during the 15 weeks of the study period.
100 % uptake is defined as administration of all study drugs and compliance to study visits during the course of 15 weeks.
15 weeks
Secondary Outcomes (3)
Proportion of those with 60% uptake of PMC drugs during the 15 weeks of the study period.
15 weeks
Proportion of those with 30 % uptake of PMC drugs during the 15 week trial period.
15 weeks
Proportion of those with <30% uptake of PMC drugs during the 15 week trial period.
15 weeks
Other Outcomes (3)
All-causes of deaths and all-causes of hospital re-admissions during the 15 week trial period.
15 weeks
Assessment of the added costs of the interventions to the health system and the individual patients by conducting interviews during the 15 week trial period.
15 weeks
Assessment of how the study interventions are acceptable by patients and health workers by conducting focus group discussions and using self administered questionnaires during the 15 week trial period.
15 weeks
Study Arms (5)
Drug + short message(SMS) reminder
OTHERdihydroartemesinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with SMS reminders prior to each treatment course
Drug + no short message(SMS) reminder
OTHERdihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) without SMS reminders prior to each treatment course.
Drug+ Health worker reminder
OTHERdihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with Health surveillance assistants reminders prior to each treatment course.
Drug at hospital + SMS reminder
OTHERdihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) collected at the outpatient department without an SMS reminders prior to each treatment course.
Drug at Hospital+no SMS reminder
OTHERdihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) collected at the outpatient department with a short message reminder prior to each treatment course
Interventions
Health surveillance assistants reminders prior to each treatment course
Eligibility Criteria
You may qualify if:
- Haemoglobin \<5.0g/dl or PCV \<15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital
- Age between 4 months (inclusive) and 59 months (inclusive)
- Body weight \>5kgs
- Screening (in-hospital):
- Fulfilled the pre-study screening eligibility criteria
- Clinically stable, able to switch to oral medication
- Subject completed blood transfusion(s) in accordance with routine hospital practice
- Able to feed (for breastfed children) or eat (for older children)
- Absence of known cardiac problems
- Provision of informed consent by parent or guardian
- Randomization (at discharge):
- Fulfilled screening eligibility criteria
- Still clinically stable, able to take oral medication, able to feed (for breastfed children) or eat (for older children) and able to sit unaided (for older children who were able to do so prior to hospitalization
You may not qualify if:
- Recognised specific other cause of severe anaemia (e.g. trauma, haematological malignancy, known bleeding disorder)
- Known sickle cell
- Child will reside for more than 25% of the 3.5months study period (i.e. 3 weeks or more) outside of catchment area Enrolment in the study (t=0) at discharge
- Previous enrolment in the present study
- Known hypersensitivity to study drug
- Sickle cell disease
- Known need at the time of enrolment for concomitant prohibited medication during the 14 weeks PMC treatment period.
- On-going or planned participation into another clinical trial involving on-going or scheduled treatment with medicinal products during the course of the study (3.5 months from enrolment)
- Known need, or scheduled surgery during the course of the study (3.5 months)
- Suspected non-compliance with the follow-up schedule
- Known heart conditions, or family history of congenital prolongation of the QTc interval
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kamuzu University of Health Scienceslead
- University of Bergencollaborator
- The Research Council of Norwaycollaborator
- Makerere Universitycollaborator
- Liverpool School of Tropical Medicinecollaborator
- Kenya Medical Research Institutecollaborator
- University of Amsterdamcollaborator
- Imperial College Londoncollaborator
- London School of Hygiene and Tropical Medicinecollaborator
- University of Minnesotacollaborator
- Ministry of Health and Population, Malawicollaborator
- Ministry of Health, Malawicollaborator
Study Sites (1)
College Of Medicine,Training and Research Unit Of Excellence,Zomba Central Hospital
Zomba, 0000, Malawi
Related Publications (4)
Nkosi-Gondwe T, Robberstad B, Mukaka M, Idro R, Opoka RO, Banda S, Kuhl MJ, O Ter Kuile F, Blomberg B, Phiri KS. Adherence to community versus facility-based delivery of monthly malaria chemoprevention with dihydroartemisinin-piperaquine for the post-discharge management of severe anemia in Malawian children: A cluster randomized trial. PLoS One. 2021 Sep 10;16(9):e0255769. doi: 10.1371/journal.pone.0255769. eCollection 2021.
PMID: 34506503DERIVEDNkosi-Gondwe T, Robberstad B, Blomberg B, Phiri KS, Lange S. Introducing post-discharge malaria chemoprevention (PMC) for management of severe anemia in Malawian children: a qualitative study of community health workers' perceptions and motivation. BMC Health Serv Res. 2018 Dec 19;18(1):984. doi: 10.1186/s12913-018-3791-5.
PMID: 30567567DERIVEDGondwe T, Robberstad B, Mukaka M, Lange S, Blomberg B, Phiri K. Delivery strategies for malaria chemoprevention with monthly dihydroartemisinin-piperaquine for the post-discharge management of severe anaemia in children aged less than 5 years old in Malawi: a protocol for a cluster randomized trial. BMC Pediatr. 2018 Jul 20;18(1):238. doi: 10.1186/s12887-018-1199-3.
PMID: 30029620DERIVEDSvege S, Kaunda B, Robberstad B, Nkosi-Gondwe T, Phiri KS, Lange S. Post-discharge malaria chemoprevention (PMC) in Malawi: caregivers; acceptance and preferences with regard to delivery methods. BMC Health Serv Res. 2018 Jul 11;18(1):544. doi: 10.1186/s12913-018-3327-z.
PMID: 29996833DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kamija Phiri, PhD
University of Malawi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2016
First Posted
March 29, 2016
Study Start
March 24, 2016
Primary Completion
March 1, 2019
Study Completion
December 1, 2019
Last Updated
February 1, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share