Phase 4
N=246
Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)
Malaria,Falciparum
Bottom Line
View on ClinicalTrials.gov: NCT03178643 ↗Enrolled (actual)
246
Serious AEs
25.6%
Results posted
Mar 2024
Primary outcome: Primary: Incidence of Clinical Malaria Per Patient Year — 0.04; 3.05; 1.36 episodes/patient year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Proguanil Oral Tablet (Drug); Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ) (Drug); Dihydroartemisinin-Piperaquine (DP) (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Clinical Malaria Per Patient Year |
0.04; 3.05; 1.36 | — |
| SECONDARY Number of Participants With Severe Anemia |
8; 9; 4 | — |
| SECONDARY Number of Participants With Severe Malaria |
0; 0; 0 | — |
| SECONDARY Number of Participants With Hospitalization for Malaria |
3; 3; 3 | — |
| SECONDARY Number of Participants With Light Microscopy (LM)-Positive Malaria |
17; 11; 19 | — |
| SECONDARY Number of Participants With Unconfirmed Malaria |
42; 25; 40 | — |
| SECONDARY Number of Participants With Fatal Malaria |
0; 0; 0 | — |
| SECONDARY Number of Participants With Asymptomatic Parasitization |
45; 20; 9 | — |
| SECONDARY Number of Participants With Painful Events |
33; 28; 30 | — |
| SECONDARY Number of Participants With Dactylitis |
81; 57; 37 | — |
| SECONDARY Number of Participants With Transfusions |
13; 7; 4 | — |
| SECONDARY Number of Participants With Acute Chest Syndrome |
1; 3; 0 | — |
| SECONDARY Number of Participants With All-cause Hospitalization |
47; 52; 40 | — |
| SECONDARY All-cause Deaths |
2; 7; 1 | — |
| SECONDARY Molecular Markers of Malaria Parasite Drug Resistance |
— | — |
Summary
This is a randomized, three-arm, open-label, clinical trial of malaria chemoprevention in children with sickle-cell anemia (SCA) at a single site in Homa Bay, Kenya. The study will enroll 246 children under 10 years of age, randomize participants 1:1:1 to one of three malaria chemoprevention regimens, and follow participants monthly for 12 months in order to record clinical episodes of malaria or SCA-related morbidity. Analyses will compare the efficacy of each regimen to prevent malaria and SCA morbidity.
Eligibility Criteria
Inclusion Criteria
- Age greater than 12 months and less than 10 years at enrollment;
- Current attendance at or willingness to attend the study SCA clinic at HBCH;
- Residence in either Homa Bay County or the Rongo or Awendo sub-counties of Migori County;
- Confirmed hemoglobin genotype of HbSS by electrophoresis, HPLC, or PCR;
- No immediate, apparent, or reported plans to relocate residence from Homa Bay County or the Rongo or Awendo sub-counties of Migori County in the next 2 years;
- Ability to take oral medication and be willing to adhere to the medication regimen or caregiver willingness to give the medical regimen as prescribed;
- Ability and willingness of parent or legally authorized representative (LAR) to give informed consent;
- Assent of child in those > 7 years.
Exclusion Criteria
- Taking routine antimalarial prophylaxis for another indication (including co-trimoxazole for HIV infection);
- Temperature of ≥ 37.5C at screening or history of objective or subjective fever in the preceding 24 hours during screening;
- Known allergy or sensitivity to sulfadoxine, pyrimethamine, amodiaquine, proguanil, dihydroartemisinin, piperaquine, artemether, lumefantrine, pencillin (if under 5 years old), or derivatives of these compounds;
- Known chronic medical condition other than SCA (i.e. malignancy, HIV) requiring frequent medical attention;
- Currently participating in another clinical research study, or having participated in one in the prior 30 days;
- Living in the same household as a previously-enrolled study participant;
- Chronic use of medications known to prolong the QT interval in children (see Appendix J);
- Fridericia's corrected QT interval (QTcF) interval > 450msec.
Data sourced from ClinicalTrials.gov (NCT03178643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.