Trial · NCT03178643

Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)

NCT03178643, Phase 4, Completed, Duke University; results first posted 2024-03-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE). Trials, record NCT03178643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03178643

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Enhancing Preventive Therapy of Malaria In Children With Sickle Cell Anemia in East Africa (EPiTOMISE)
NCT number: NCT03178643
Status: Completed
Phases: Phase 4
Enrollment: 246 participants, actual
Lead sponsor: Duke University
Conditions: Malaria,Falciparum
Interventions: Proguanil Oral Tablet, Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ), Dihydroartemisinin-Piperaquine (DP)
First posted: 2017-06-07
Last updated: 2024-04-23
Results first posted: 2024-03-27

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of Clinical Malaria Per Patient Year	12 months	The primary endpoint is the cumulative incidence of clinical malaria expressed as episodes per person-year at risk. Time at risk will begin when study participants are randomized and receive study drug (i.e. begin chemoprevention) and end when participants reach the end of the observation period.
Secondary	Number of Participants With Severe Anemia	12 months	E.g., hemoglobin \<5.5 g/dL
Secondary	Number of Participants With Severe Malaria	12 months	Positive rapid diagnostic test (RDT).
Secondary	Number of Participants With Hospitalization for Malaria	12 months	Patient admitted to hospital for malaria with confirmed positive RDT.
Secondary	Number of Participants With Light Microscopy (LM)-Positive Malaria	12 months	LM-positive malaria defined as the reported presence of P. falciparum parasites detected by LM irrespective of RDT or other detection results.
Secondary	Number of Participants With Unconfirmed Malaria	12 months	Defined as the receipt of antimalarials for suspected malaria episodes that were not confirmed by any objective diagnostic test.
Secondary	Number of Participants With Fatal Malaria	12 months	Defined as death during hospitalization for malaria with positive RDT.
Secondary	Number of Participants With Asymptomatic Parasitization	12 months	Defined as the presence of parasites during routine follow-up visits as detected by PCR in patients without fever or a history of recent fever.
Secondary	Number of Participants With Painful Events	12 months	Pain lasting two hours or more without obvious cause.
Secondary	Number of Participants With Dactylitis	12 months	Pain or tenderness with or without swelling of the hands or feet.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Incidence of Clinical Malaria Per Patient Year	12 months	episodes/patient year	NUMBER
SECONDARY	Number of Participants With Severe Anemia	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Severe Malaria	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Hospitalization for Malaria	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Light Microscopy (LM)-Positive Malaria	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Unconfirmed Malaria	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Fatal Malaria	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Asymptomatic Parasitization	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Painful Events	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Dactylitis	12 months	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Incidence of Clinical Malaria Per Patient Year	Proguanil Oral Tablet	0.04	episodes/patient year
Incidence of Clinical Malaria Per Patient Year	Sulfadoxine/Pyrimethanine-Amodiaquine	3.05	episodes/patient year
Incidence of Clinical Malaria Per Patient Year	Dihydroartemisinin-Piperaquine (DP)	1.36	episodes/patient year
Number of Participants With Severe Anemia	Proguanil Oral Tablet	8	Participants
Number of Participants With Severe Anemia	Sulfadoxine/Pyrimethanine-Amodiaquine	9	Participants
Number of Participants With Severe Anemia	Dihydroartemisinin-Piperaquine (DP)	4	Participants
Number of Participants With Severe Malaria	Proguanil Oral Tablet	0	Participants
Number of Participants With Severe Malaria	Sulfadoxine/Pyrimethanine-Amodiaquine	0	Participants
Number of Participants With Severe Malaria	Dihydroartemisinin-Piperaquine (DP)	0	Participants
Number of Participants With Hospitalization for Malaria	Proguanil Oral Tablet	3	Participants

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Proguanil Oral Tablet	81
Overall Study	STARTED	Sulfadoxine/Pyrimethanine-Amodiaquine	83
Overall Study	STARTED	Dihydroartemisinin-Piperaquine (DP)	82
Overall Study	COMPLETED	Proguanil Oral Tablet	75
Overall Study	COMPLETED	Sulfadoxine/Pyrimethanine-Amodiaquine	67
Overall Study	COMPLETED	Dihydroartemisinin-Piperaquine (DP)	71
Overall Study	NOT COMPLETED	Proguanil Oral Tablet	6
Overall Study	NOT COMPLETED	Sulfadoxine/Pyrimethanine-Amodiaquine	16
Overall Study	NOT COMPLETED	Dihydroartemisinin-Piperaquine (DP)	11

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Painful Crisis	Blood and lymphatic system disorders	Proguanil Oral Tablet	22	81	33
serious	Painful Crisis	Blood and lymphatic system disorders	Sulfadoxine/Pyrimethanine-Amodiaquine	22	83	28
serious	Painful Crisis	Blood and lymphatic system disorders	Dihydroartemisinin-Piperaquine (DP)	19	82	30
serious	Anemia	Blood and lymphatic system disorders	Proguanil Oral Tablet	10	81	12
serious	Anemia	Blood and lymphatic system disorders	Sulfadoxine/Pyrimethanine-Amodiaquine	12	83	14
serious	Anemia	Blood and lymphatic system disorders	Dihydroartemisinin-Piperaquine (DP)	7	82	7

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Proguanil Oral Tablet	2	81
Total, all-cause mortality	Sulfadoxine/Pyrimethanine-Amodiaquine	7	83
Total, all-cause mortality	Dihydroartemisinin-Piperaquine (DP)	1	82
Total, other adverse events	Proguanil Oral Tablet	0	0
Total, other adverse events	Sulfadoxine/Pyrimethanine-Amodiaquine	0	0
Total, other adverse events	Dihydroartemisinin-Piperaquine (DP)	0	0
Total, serious adverse events	Proguanil Oral Tablet	22	81
Total, serious adverse events	Sulfadoxine/Pyrimethanine-Amodiaquine	22	83
Total, serious adverse events	Dihydroartemisinin-Piperaquine (DP)	19	82

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36215323	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL134211	Malaria chemoprevention in children with sickle cell anemia in Western Kenya	TAYLOR, STEVE MYER	DUKE UNIVERSITY	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2016 to 2020

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

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