Trial Outcomes & Findings for Novel Use Of Hydroxyurea in an African Region With Malaria (NCT NCT01976416)
NCT ID: NCT01976416
Last Updated: 2018-12-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
208 participants
Primary outcome timeframe
12 months
Results posted on
2018-12-04
Participant Flow
Participant milestones
| Measure |
Hydroxyurea
Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months
Hydroxyurea
|
Placebo
Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
104
|
|
Overall Study
COMPLETED
|
102
|
102
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hydroxyurea
n=104 Participants
Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months
Hydroxyurea
|
Placebo
n=103 Participants
Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months
Placebo
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age 1.00-3.99 years
|
104 Participants
n=104 Participants
|
103 Participants
n=103 Participants
|
207 Participants
n=207 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=104 Participants
|
46 Participants
n=103 Participants
|
95 Participants
n=207 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=104 Participants
|
57 Participants
n=103 Participants
|
112 Participants
n=207 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Uganda
|
104 participants
n=104 Participants
|
103 participants
n=103 Participants
|
207 participants
n=207 Participants
|
PRIMARY outcome
Timeframe: 12 monthsMalaria 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.
Outcome measures
| Measure |
Hydroxyurea
n=104 person-years
Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months
Hydroxyurea
|
Placebo
n=103 person-years
Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months
Placebo
|
|---|---|---|
|
Number of Malaria Episodes
|
5 malaria episodes
|
7 malaria episodes
|
Adverse Events
Hydroxyurea
Serious events: 6 serious events
Other events: 76 other events
Deaths: 2 deaths
Placebo
Serious events: 6 serious events
Other events: 88 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Hydroxyurea
n=104 participants at risk
Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months
Hydroxyurea
|
Placebo
n=103 participants at risk
Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months
Placebo
|
|---|---|---|
|
Infections and infestations
Bacteremia
|
1.9%
2/104 • Number of events 2 • 1 year
|
1.9%
2/103 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.96%
1/104 • Number of events 1 • 1 year
|
1.9%
2/103 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Vaso-Occlusive Crisis
|
0.00%
0/104 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Acute Splenic Squestration
|
1.9%
2/104 • Number of events 2 • 1 year
|
0.00%
0/103 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/104 • 1 year
|
0.97%
1/103 • Number of events 1 • 1 year
|
|
General disorders
Sudden Death
|
0.96%
1/104 • Number of events 1 • 1 year
|
0.00%
0/103 • 1 year
|
Other adverse events
| Measure |
Hydroxyurea
n=104 participants at risk
Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months
Hydroxyurea
|
Placebo
n=103 participants at risk
Fixed dose 20 ± 2.5 mg/kg/day, administered once a day in tablet form (100mg or scored 1000mg) for twelve months
Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Vaso-Occlusive Crisis
|
36.5%
38/104 • Number of events 58 • 1 year
|
57.3%
59/103 • Number of events 106 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
20.2%
21/104 • Number of events 24 • 1 year
|
23.3%
24/103 • Number of events 32 • 1 year
|
|
Infections and infestations
Clinical Sepsis
|
5.8%
6/104 • Number of events 8 • 1 year
|
12.6%
13/103 • Number of events 16 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
51.9%
54/104 • Number of events 107 • 1 year
|
60.2%
62/103 • Number of events 108 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal-related
|
12.5%
13/104 • Number of events 15 • 1 year
|
11.7%
12/103 • Number of events 15 • 1 year
|
|
Blood and lymphatic system disorders
Malaria
|
2.9%
3/104 • Number of events 5 • 1 year
|
6.8%
7/103 • Number of events 7 • 1 year
|
|
Infections and infestations
Other infections
|
6.7%
7/104 • Number of events 8 • 1 year
|
13.6%
14/103 • Number of events 14 • 1 year
|
|
Injury, poisoning and procedural complications
Others (e.g., injury)
|
6.7%
7/104 • Number of events 7 • 1 year
|
8.7%
9/103 • Number of events 10 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
24.0%
25/104 • Number of events 40 • 1 year
|
40.8%
42/103 • Number of events 65 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.6%
11/104 • Number of events 12 • 1 year
|
3.9%
4/103 • Number of events 4 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place