Trial · NCT01976416

Novel Use Of Hydroxyurea in an African Region With Malaria

NCT01976416, Phase 3, Completed, Indiana University; results first posted 2018-10-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Novel Use Of Hydroxyurea in an African Region With Malaria. Trials, record NCT01976416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01976416

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Trial

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

Title: Novel Use Of Hydroxyurea in an African Region With Malaria
NCT number: NCT01976416
Status: Completed
Phases: Phase 3
Enrollment: 208 participants, actual
Lead sponsor: Indiana University
Conditions: Sickle Cell Anemia, Sickle Cell Disease, Malaria
Interventions: Hydroxyurea, Placebo
First posted: 2013-11-05
Last updated: 2018-12-04
Results first posted: 2018-10-01

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Malaria Episodes	12 months	Malaria is defined as the presence of P. falciparum or P. malariae on the peripheral smear of any child brought in for medical evaluation of fever. P. vivax, P. ovale and P. knowlesi are not known to be present in this region, but if a child is seen with suspected infection with any of these malaria parasites, this will also be recorded as a case of malaria. Incidence will be reported in the number of cases per 100 patient years.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Malaria Episodes	12 months		malaria episodes	NUMBER

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Number of Malaria Episodes	Hydroxyurea		5		malaria episodes
Number of Malaria Episodes	Placebo		7		malaria episodes

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Hydroxyurea	104
Overall Study	STARTED	Placebo	104
Overall Study	COMPLETED	Hydroxyurea	102
Overall Study	COMPLETED	Placebo	102
Overall Study	NOT COMPLETED	Hydroxyurea	2
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events32

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
other	Vaso-Occlusive Crisis	Blood and lymphatic system disorders	Hydroxyurea	38	104	58
other	Vaso-Occlusive Crisis	Blood and lymphatic system disorders	Placebo	59	103	106
other	Pneumonia	Respiratory, thoracic and mediastinal disorders	Hydroxyurea	21	104	24
other	Pneumonia	Respiratory, thoracic and mediastinal disorders	Placebo	24	103	32
other	Clinical Sepsis	Infections and infestations	Hydroxyurea	6	104	8
other	Clinical Sepsis	Infections and infestations	Placebo	13	103	16
other	Upper Respiratory Tract Infection	Respiratory, thoracic and mediastinal disorders	Hydroxyurea	54	104	107
other	Upper Respiratory Tract Infection	Respiratory, thoracic and mediastinal disorders	Placebo	62	103	108
other	Gastrointestinal-related	Gastrointestinal disorders	Hydroxyurea	13	104	15
other	Gastrointestinal-related	Gastrointestinal disorders	Placebo	12	103	15

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Hydroxyurea	2	104
Total, all-cause mortality	Placebo	1	103
Total, other adverse events	Hydroxyurea	76	104
Total, other adverse events	Placebo	88	103
Total, serious adverse events	Hydroxyurea	6	104
Total, serious adverse events	Placebo	6	103

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27339303	DERIVED	PubMed
29051184	RESULT	PubMed
31135090	DERIVED	PubMed
40765704	DERIVED	PubMed
41026975	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons2

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

Comparison	Source
Hydroxyurea vs Placebo: deaths from any cause	Trial comparisons
Hydroxyurea vs Placebo: serious adverse events	Trial comparisons

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01976416

GET https://conductscience.org/api/trials/v1/NCT01976416/events?page=2

API reference For AI assistants