MalariaPhase 3PMCNCT02721420
Delivery of Malaria Chemoprevention in the Post-discharge Management of Children With Severe Anaemia in Malawi
A Phase 3 study testing dihydroartemisinin-piperaquine, message(SMS) reminder and Health worker reminder in people with Malaria and Severe Anemia, run by Kamuzu University of Health Sciences at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 59 months
- Conditions the study is for
- Malaria, Severe Anemia
- What is being tested?
- dihydroartemisinin-piperaquine, message(SMS) reminder and Health worker reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteMalawi
- Study dates
- 24 Mar 2016to Dec 2019
- Phase
- Phase 3
- 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 4 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Malawi1 site, 1 recruiting
- Recruiting
College Of Medicine,Training and Research Unit Of Excellence,Zomba Central Hospital
Zomba, 0000
Thandile Nkosi-Gondwe, MBBS, +265995508830, tgondwe@medcol.mw
Kamija Phiri, PhD, +265999957048, kphiri@medcol.mw
About this study
Official title: Malaria Chemoprevention With Monthly Treatment With Dihydroartemisinin-Piperaquine for the Post-discharge Management of Severe Anaemia in Children Less Than 5 Years in Malawi
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.
Read the detailed description
Objectives: The primary objective of the trial is to determine the optimum PMC delivery mechanism by comparing community- versus health facility-based strategies in order to inform policy.
Study Type: This is a single-centre, matched, cluster randomized, 5-arm, factorial design trial comparing the uptake of PMC-DHP delivered through health facility or community-based approaches with or without SMS/HSA reminders.
Site: 90 villages in the catchment areas of Zomba Central hospital in southern Malawi
Study Population:
Inclusion criteria: convalescent children aged less than 5 years and weighing >5 kg admitted with severe anaemia (haemoglobin<5g/dL / Ht<15%); clinically stable, able to take or switch to oral medication; post-transfusion Hb >5g/dL.
Exclusion criteria: blood loss due to trauma, malignancy, known bleeding disorders or sickle cell trait, known hypersensitivity to study drug, known heart conditions, non-resident in study area, previous participation in study, known need at enrolment for prohibited medication and scheduled surgery during the course of the study. HIV infection and cotrimoxazole prophylaxis are not exclusion criteria
Study Interventions:
All children will receive Dihydroartemisinin-piperaquine (3-day treatment courses, given 2,6 and 10 weeks after discharge) either:
- at discharge + SMS Reminder;
- at discharge + No SMS Reminder;
- at discharge + HSA Reminder;
- at OPD + SMS Reminder; or
- at OPD + No SMS Reminder
Outcome Measures:
Primary: 100% of PMC drugs uptake (defined as administration of all 3-day treatment courses, given 2, 6 and 10 weeks after discharge) assessed by unannounced spot checks.
Follow-up procedures: Children will be followed up for 15 weeks by passive case detection in 2 phases: Pre-PMC (2 weeks between hospital admission and 2 weeks post-discharge); PMC (2-14 weeks post-discharge)
Sample Size: A sample size of 75 children per arm (375 total children) allows for a detection of 25% increase in uptake from 50% to 75% with 10% loss to follow-up (power 90%, α=0.05).
Data Analysis: The % of children receiving IPTpd according to schedule will be compared by relative risks (95% CI), adjusted for prognostic factors at baseline using log binomial or Poisson regression with adjustment for cluster effects
- Conditions
- Malaria, Severe Anemia
- Being tested
- dihydroartemisinin-piperaquine, message(SMS) reminder, Health worker reminder, short message(SMS) reminder
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dihydroartemisinin-piperaquineDrug
message(SMS) reminderOther
Health worker reminderOther
Health surveillance assistants reminders prior to each treatment course
short message(SMS) reminderOther
| Study group | Role | What they receive |
|---|---|---|
| Drug + short message(SMS) reminder | Other | dihydroartemesinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with SMS reminders prior to each treatment course Receives: Drug: dihydroartemisinin-piperaquine; Other: short message(SMS) reminder |
| Drug + no short message(SMS) reminder | Other | dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) without SMS reminders prior to each treatment course. Receives: Drug: dihydroartemisinin-piperaquine |
| Drug+ Health worker reminder | Other | dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with Health surveillance assistants reminders prior to each treatment course. Receives: Drug: dihydroartemisinin-piperaquine; Other: Health worker reminder |
| Drug at hospital + SMS reminder | Other | dihydroartemisinin-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. Receives: Drug: dihydroartemisinin-piperaquine |
| Drug at Hospital+no SMS reminder | Other | dihydroartemisinin-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 Receives: Drug: dihydroartemisinin-piperaquine; Other: message(SMS) reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 weeks
Secondary outcomes (3)
Proportion of those with 60% uptake of PMC drugs during the 15 weeks of the study period.
60 % uptake is defined as administration of 6 or more [but less than 9] of the daily dosages out of the total of 9 during the 15 week study period.
Measured: 15 weeks
Proportion of those with 30 % uptake of PMC drugs during the 15 week trial period.
30 % PMC uptake is defined as administration of 3 or more [but less than 6] of the daily dosages out of the total of 9 during the 15 week trial period.
Measured: 15 weeks
Proportion of those with <30% uptake of PMC drugs during the 15 week trial period.
<30 % PMC uptake is defined as administration of less than 3 of the daily dosages out of the total of 9 assessed during the 15 week trial period.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start24 Mar 2016
- Primary completionMar 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kamuzu University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, The Research Council of Norway, Makerere University, Liverpool School of Tropical Medicine, Kenya Medical Research Institute, University of Amsterdam, Imperial College London, London School of Hygiene and Tropical Medicine, University of Minnesota, Ministry of Health, Malawi
- Responsible party
- Sponsor
- Investigators
- Kamija Phiri, PhD, Principal investigator, University of Malawi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721420
- Sponsor's protocol ID
- P.02/15/1679
- Acronym
- PMC
- Status last verified
- Jan 2018
- First submitted
- 13 Feb 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34506503Nkosi-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.
PubMed 30567567Gondwe 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.
PubMed 30029620Svege 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.
PubMed 29996833
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malaria Chemoprevention With Monthly Treatment With Dihydroartemisinin-Piperaquine for the Post-discharge Management of Severe Anaemia in Children Less Than 5 Years in Malawi
- ClinicalTrials.gov ID
- NCT02721420
- Acronym / sponsor ID
- PMC / P.02/15/1679
- Conditions
- Malaria, Severe Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Kamuzu University of Health SciencesUniversity, hospital or other
- Collaborators
- University of Bergen, The Research Council of Norway, Makerere University, Liverpool School of Tropical Medicine, Kenya Medical Research Institute, University of Amsterdam, Imperial College London, London School of Hygiene and Tropical Medicine, University of Minnesota, Ministry of Health, Malawi
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Mar 2016 (estimated)
- 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.
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.
Detailed description
Objectives: The primary objective of the trial is to determine the optimum PMC delivery mechanism by comparing community- versus health facility-based strategies in order to inform policy.
Study Type: This is a single-centre, matched, cluster randomized, 5-arm, factorial design trial comparing the uptake of PMC-DHP delivered through health facility or community-based approaches with or without SMS/HSA reminders.
Site: 90 villages in the catchment areas of Zomba Central hospital in southern Malawi
Study Population:
Inclusion criteria: convalescent children aged less than 5 years and weighing >5 kg admitted with severe anaemia (haemoglobin<5g/dL / Ht<15%); clinically stable, able to take or switch to oral medication; post-transfusion Hb >5g/dL.
Exclusion criteria: blood loss due to trauma, malignancy, known bleeding disorders or sickle cell trait, known hypersensitivity to study drug, known heart conditions, non-resident in study area, previous participation in study, known need at enrolment for prohibited medication and scheduled surgery during the course of the study. HIV infection and cotrimoxazole prophylaxis are not exclusion criteria
Study Interventions:
All children will receive Dihydroartemisinin-piperaquine (3-day treatment courses, given 2,6 and 10 weeks after discharge) either:
- at discharge + SMS Reminder;
- at discharge + No SMS Reminder;
- at discharge + HSA Reminder;
- at OPD + SMS Reminder; or
- at OPD + No SMS Reminder
Outcome Measures:
Primary: 100% of PMC drugs uptake (defined as administration of all 3-day treatment courses, given 2, 6 and 10 weeks after discharge) assessed by unannounced spot checks.
Follow-up procedures: Children will be followed up for 15 weeks by passive case detection in 2 phases: Pre-PMC (2 weeks between hospital admission and 2 weeks post-discharge); PMC (2-14 weeks post-discharge)
Sample Size: A sample size of 75 children per arm (375 total children) allows for a detection of 25% increase in uptake from 50% to 75% with 10% loss to follow-up (power 90%, α=0.05).
Data Analysis: The % of children receiving IPTpd according to schedule will be compared by relative risks (95% CI), adjusted for prognostic factors at baseline using log binomial or Poisson regression with adjustment for cluster effects
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Drug + short message(SMS) reminder | Other | Drug: dihydroartemisinin-piperaquine, Other: short message(SMS) reminderdihydroartemesinin-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 | Other | Drug: dihydroartemisinin-piperaquinedihydroartemisinin-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 | Other | Drug: dihydroartemisinin-piperaquine, Other: Health worker reminderdihydroartemisinin-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 | Other | Drug: dihydroartemisinin-piperaquinedihydroartemisinin-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 | Other | Drug: dihydroartemisinin-piperaquine, Other: message(SMS) reminderdihydroartemisinin-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 |
Who may qualify
- Ages
- 4 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
- Fulfilled the pre-study screening eligibility criteria
- Clinically stable, able to switch to oral medication
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| dihydroartemisinin-piperaquine | Drug | Drug + no short message(SMS) reminder, Drug + short message(SMS) reminder, Drug at Hospital+no SMS reminder, Drug at hospital + SMS reminder, Drug+ Health worker reminder |
| message(SMS) reminder | Other | Drug at Hospital+no SMS reminder |
| Health worker reminderHealth surveillance assistants reminders prior to each treatment course | Other | Drug+ Health worker reminder |
| short message(SMS) reminder | Other | Drug + short message(SMS) reminder |
Primary outcome
Proportion of those with 100 % uptake of PMC drugs during the 15 weeks of the study period.
Time frame: 15 weeks
100 % uptake is defined as administration of all study drugs and compliance to study visits during the course of 15 weeks.
3 secondary outcomes
Proportion of those with 60% uptake of PMC drugs during the 15 weeks of the study period.
Time frame: 15 weeks
Proportion of those with 30 % uptake of PMC drugs during the 15 week trial period.
Time frame: 15 weeks
Proportion of those with <30% uptake of PMC drugs during the 15 week trial period.
Time frame: 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Derived from this study: PubMed 34506503Nkosi-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.
- Derived from this study: PubMed 30567567Nkosi-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.
- Derived from this study: PubMed 30029620Gondwe 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.
- Derived from this study: PubMed 29996833Svege 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.
- Individual participant dataSharing planned: No
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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.
Kamija Phiri, PhD principal investigator
University of Malawi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dihydroartemisinin-piperaquine, message(SMS) reminder and Health worker reminder in people with Malaria and Severe Anemia, run by Kamuzu University of Health Sciences at 1 site in Malawi.
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 13 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Feb 2018. 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 Malawi. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamija Phiri, PhD (+265999957048, kphiri@medcol.mw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of those with 100 % uptake of PMC drugs during the 15 weeks of the study period. (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02721420, which also lists 4 linked publications.
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 1 Feb 2018.