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Novel Use Of Hydroxyurea in an African Region With Malaria (NOHARM)

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ClinicalTrials.gov Identifier: NCT01976416
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : October 1, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
Doris Duke Charitable Foundation
Makerere University
Mulago Hospital, Uganda
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Chandy John, Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Sickle Cell Anemia
Sickle Cell Disease
Malaria
Interventions Drug: Hydroxyurea
Drug: Placebo
Enrollment 208
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hydroxyurea Placebo
Hide Arm/Group Description

Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months

Hydroxyurea

Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months

Placebo

Period Title: Overall Study
Started 104 104
Completed 102 102
Not Completed 2 2
Arm/Group Title Hydroxyurea Placebo Total
Hide Arm/Group Description

Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months

Hydroxyurea

Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 104 103 207
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age 1.00-3.99 years Number Analyzed 104 participants 103 participants 207 participants
104
 100.0%
103
 100.0%
207
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 103 participants 207 participants
Female
49
  47.1%
46
  44.7%
95
  45.9%
Male
55
  52.9%
57
  55.3%
112
  54.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Uganda Number Analyzed 104 participants 103 participants 207 participants
104 103 207
1.Primary Outcome
Title Number of Malaria Episodes
Hide Description 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydroxyurea Placebo
Hide Arm/Group Description:

Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months

Hydroxyurea

Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months

Placebo

Overall Number of Participants Analyzed 104 103
Overall Number of Units Analyzed
Type of Units Analyzed: Person-years
104 103
Measure Type: Number
Unit of Measure: malaria episodes
5 7
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hydroxyurea Placebo
Hide Arm/Group Description

Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months

Hydroxyurea

Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months

Placebo

All-Cause Mortality
Hydroxyurea Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/104 (1.92%)      1/103 (0.97%)    
Hide Serious Adverse Events
Hydroxyurea Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/104 (5.77%)      6/103 (5.83%)    
Blood and lymphatic system disorders     
Vaso-Occlusive Crisis  1  0/104 (0.00%)  0 1/103 (0.97%)  1
Acute Splenic Squestration  1  2/104 (1.92%)  2 0/103 (0.00%)  0
Anemia  1  0/104 (0.00%)  0 1/103 (0.97%)  1
General disorders     
Sudden Death  1  1/104 (0.96%)  1 0/103 (0.00%)  0
Infections and infestations     
Bacteremia  1  2/104 (1.92%)  2 2/103 (1.94%)  2
Respiratory, thoracic and mediastinal disorders     
Pneumonia  1  1/104 (0.96%)  1 2/103 (1.94%)  2
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hydroxyurea Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/104 (73.08%)      88/103 (85.44%)    
Blood and lymphatic system disorders     
Vaso-Occlusive Crisis  1  38/104 (36.54%)  58 59/103 (57.28%)  106
Malaria  1  3/104 (2.88%)  5 7/103 (6.80%)  7
Anemia  1  25/104 (24.04%)  40 42/103 (40.78%)  65
Thrombocytopenia  1  11/104 (10.58%)  12 4/103 (3.88%)  4
Gastrointestinal disorders     
Gastrointestinal-related  1  13/104 (12.50%)  15 12/103 (11.65%)  15
Infections and infestations     
Clinical Sepsis  1  6/104 (5.77%)  8 13/103 (12.62%)  16
Other infections  1  7/104 (6.73%)  8 14/103 (13.59%)  14
Injury, poisoning and procedural complications     
Others (e.g., injury)  1  7/104 (6.73%)  7 9/103 (8.74%)  10
Respiratory, thoracic and mediastinal disorders     
Pneumonia  1  21/104 (20.19%)  24 24/103 (23.30%)  32
Upper Respiratory Tract Infection  1  54/104 (51.92%)  107 62/103 (60.19%)  108
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Chandy John
Organization: Indiana University
Phone: 317-274-8940
EMail: chjohn@iu.edu
Layout table for additonal information
Responsible Party: Chandy John, Indiana University
ClinicalTrials.gov Identifier: NCT01976416    
Other Study ID Numbers: 2012139
First Submitted: October 22, 2013
First Posted: November 5, 2013
Results First Submitted: February 2, 2018
Results First Posted: October 1, 2018
Last Update Posted: December 4, 2018