Post-discharge Malaria Chemoprevention(PMC) Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02671175
• Date of registration: 28/01/2016
• Prospective Registration: Yes
• Primary sponsor: Liverpool School of Tropical Medicine
• Public title: Post-discharge Malaria Chemoprevention(PMC) Study PMC
• Scientific title: Malaria Chemoprevention With Monthly Treatment With Dihydroartemisinin-piperaquine for the Post-discharge Management of Severe Anaemia in Children Aged Less Than 5 Years in Uganda and Kenya: A Two-arm Randomised Placebo Controlled Trial
• Date of first enrolment: May 20, 2016
• Target sample size: 1049
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02671175
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Kenya, Uganda

Contacts

• Name: Dr Simon K Kariuki, PhD
• Affiliation: Kenya Medical Research Institute

• Name: Dr Titus K Kwambai, MSc
• Affiliation: Liverpool School of Tropical Medicine

• Name: Dr Richard IDRO, PhD
• Affiliation: Makerere University

• Name: Dr Robert Opoka, M.Med
• Affiliation: Makerere University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pre-study screening

1. Haemoglobin <5.0 g/dl or PCV < 15%, or requirement for blood transfusion for
other clinical reasons on or during admission to the hospital

2. Aged less than 59.5 months

3. Body weight >5 kg

4. Resident in catchment area Enrolment in study(t=0)

1. Fulfilled the pre-study screening eligibility criteria

2. Aged < 59.5 months

3. Clinically stable, able to take oral medication

4. Subject completed blood transfusion(s) or became clinically stable without
transfusion

5. Able to feed (for breastfeeding children) or eat (for older children)

6. Absence of know cardiac problems

7. Provision of informed consent by parent or guardian Randomisation (t=2 weeks)

1. Fulfilled enrolment eligibility criteria and was enrolled during recent admission

2. Aged <60 months

3. Still clinically stable, able to take to oral medication, able to feed (for
breastfeeding children) or eat (for older children) and able to sit unaided (for
older children who were already able to do so prior to hospitalisation)

Exclusion Criteria:

- Pre-study screening

1. Recognised specific other cause of severe anaemia (e.g. trauma, haematological
malignancy, known bleeding disorder)

2. Known sickle cell disease

3. Anticipated to reach the 5th birthday (60 months of age) within 2 weeks from
enrolment (i.e. prior to randomization)

4. Child will reside for more than 25%of the 6 months study period (i.e. 6 weeks or
more) outside of catchment area Enrolment in study (t=0)

1. Previous enrolment in the present study

2. Known hypersensitivity to study drug

3. Sickle cell disease

4. Use or known need at the time of enrolment for concomitant prohibited medication
during the 14 weeks PMC treatment period.

5. Ongoing or planned participation in another clinical trial involving ongoing or
scheduled treatment with prohibited medicinal products or active follow-up during
the course of the study (6 months from enrolment)

6. A known need at the time of enrolment for scheduled surgery during the subsequent
course of the study (6 months from enrolment)

7. Suspected non-compliance with the follow-up schedule

8. Know heart conditions, or family history of congenital prolongation of the QTc
interval.

9. Taking medicinal products that are known to prolong the QTc interval
Randomisation (t=2 weeks)

1. Used dihydroartemisinin since enrolment

2. Use or known need at the time of randomisation for concomitant prohibited
medication during the 14 weeks PMC treatment period.

3. Enrolled, or known agreement to enrol into another clinical trial involving
ongoing or scheduled treatment with medicinal products during the course of the
study (6 months from enrolment)

4. A known need at the time of randomisation for scheduled surgery during the
subsequent course of the study (6 months from enrolment)

5. Suspected non-compliance with the follow-up schedule

6. Withdrawal of consent since enrolment



Age minimum: N/A
Age maximum: 60 Months
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Severe Anemia

Intervention(s)

Drug: dihydroartemisinin-piperaquine

Drug: dihydroartemisinin-piperaquine placebo

Primary Outcome(s)

All-cause deaths or all-cause re-admissions by 26 weeks from randomization (composite primary outcome). [Time Frame: 6 months]

Secondary Outcome(s)

Adverse events by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

Any anaemia (Hb<11 g/dL), mild anaemia (Hb 8.0-10.99 g/dl) moderate anaemia (Hb 5.0-7.99 g/dL) and severe anaemia (Hb<5 g/dL) at 6 months [Time Frame: 6 months]

Malaria infection at 6 month [Time Frame: 6 month]

Serious adverse events within 7 days after the start of each course of PMC, excluding primary and secondary efficacy outcomes. [Time Frame: 26 weeks from randomization]

All-cause mortality by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

All-cause readmission by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

Corrected QT interval (QTc) prolongation measured by electro cardio gram (ECG)4-6 hours after 3rd dose of each course [Time Frame: 4-6 hours after 3rd dose of each course]

Patients costs of receiving the intervention [Time Frame: 26 weeks after randomization]

Readmission due to severe anaemia or severe malaria (composite outcome)by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

Serious adverse events, excluding primary and secondary efficacy outcomes, by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

Clinic visits because of smear of rapid diagnostic test (RDT) confirmed non-severe malaria by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

Readmission due to severe disease other than severe anaemia and severe malaria by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

Adverse events within 7 days after start of each course of PMC. [Time Frame: 7 days post drug administration]

Hb at 6 months [Time Frame: 6 months]

Readmission due to severe malarial anaemia (severe anaemia plus parenteral or oral antimalarial treatment)by 26 weeks from randomization [Time Frame: 26 from randomization]

Readmissions due to severe anaemia (defined as Haemoglobin (Hb) <5g/dL or packed-cell volume (PCV) <15% or requirement for blood transfusion based on other clinical indication)by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

Weight-for-age, height-for-age, and height-for-weight Z-scores, standard deviation (SD) scores of reference population) at 6 months [Time Frame: 6 months]

Readmission due to severe malaria-specific anaemia (severe anaemia plus parenteral or oral antimalarial treatment and parasite density >5000/microlitre) by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

The costs of the health care system of providing the intervention [Time Frame: 26 weeks after randomization]

Non-malaria sick child clinic visits by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

Non-severe all-cause sick-child clinic visits by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

Patients costs related to treatment of the primary disease, readmission or death [Time Frame: 26 weeks after randomization]

Readmission due to severe malaria (defined as any treatment with parenteral quinine or artesunate, or presence of severe anaemia and treatment with oral antimalarials) by 26 weeks from randomization [Time Frame: 26 weeks from randomization]

The costs of the health system of treating the primary disease and anaemia, as well as treatment of readmissions or costs related to fatalities [Time Frame: 26 weeks after randomization]

Secondary ID(s)

2965

2015-125

2014/1911

14.034

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kenya Medical Research Institute

Makerere University

The Research Council of Norway