Trial Outcomes & Findings for Praziquantel in Children Under Age 4 (NCT NCT03640377)
NCT ID: NCT03640377
Last Updated: 2026-04-23
Results Overview
Treatment efficacy as captured by egg reduction rate with the post treatment egg count assessed four weeks after treatment baseline treatment only. This is the calculated as 1 - (Post-treatment mean egg count / pre-treatment mean egg count) x 100%
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
354 participants
Primary outcome timeframe
Four weeks after baseline treatment
Results posted on
2026-04-23
Participant Flow
Participant milestones
| Measure |
Praziquantel 40 mg/kg Dose Only Baseline Treatment
75 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose Only Baseline Treatment
75 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose at Baseline and 6 Months
75 children will receive 40 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose at Baseline and 6 Months
75 children will receive 80 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
88
|
86
|
89
|
91
|
|
Overall Study
COMPLETED
|
72
|
72
|
80
|
72
|
|
Overall Study
NOT COMPLETED
|
16
|
14
|
9
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Praziquantel in Children Under Age 4
Baseline characteristics by cohort
| Measure |
Praziquantel 40 mg/kg Dose Only Baseline Treatment
n=88 Participants
75 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose Only Baseline Treatment
n=86 Participants
75 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose at Baseline and 6 Months
n=89 Participants
75 children will receive 40 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose at Baseline and 6 Months
n=91 Participants
75 children will receive 80 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Total
n=354 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
88 Participants
n=60 Participants
|
86 Participants
n=56 Participants
|
89 Participants
n=116 Participants
|
91 Participants
n=7 Participants
|
354 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=60 Participants
|
43 Participants
n=56 Participants
|
44 Participants
n=116 Participants
|
46 Participants
n=7 Participants
|
177 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=60 Participants
|
43 Participants
n=56 Participants
|
45 Participants
n=116 Participants
|
45 Participants
n=7 Participants
|
177 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
88 Participants
n=60 Participants
|
86 Participants
n=56 Participants
|
89 Participants
n=116 Participants
|
91 Participants
n=7 Participants
|
354 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
Uganda
|
88 participants
n=60 Participants
|
86 participants
n=56 Participants
|
89 participants
n=116 Participants
|
91 participants
n=7 Participants
|
354 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Four weeks after baseline treatmentPopulation: Egg reduction rate at 4 weeks post baseline treatment among subjects who submitted both pre and post treatment stools for assessment
Treatment efficacy as captured by egg reduction rate with the post treatment egg count assessed four weeks after treatment baseline treatment only. This is the calculated as 1 - (Post-treatment mean egg count / pre-treatment mean egg count) x 100%
Outcome measures
| Measure |
Praziquantel 80 mg/kg Dose Only Baseline Treatment
n=80 Participants
75 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose at Baseline and 6 Months
n=84 Participants
75 children will receive 40 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose at Baseline and 6 Months
n=84 Participants
75 children will receive 80 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose Only Baseline Treatment
n=88 Participants
75 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
|---|---|---|---|---|
|
Treatment Efficacy
|
98 percentage change
Interval 98.0 to 99.0
|
96 percentage change
Interval 95.0 to 97.0
|
98 percentage change
Interval 98.0 to 99.0
|
96 percentage change
Interval 95.0 to 97.0
|
PRIMARY outcome
Timeframe: Four weeks after baseline treatmentPopulation: Subjects who submitted stool for assessment 4 weeks after baseline treatment
Efficacy of treatment as captured by cure rate 4 weeks after treatment at baseline. Cure rate is the percent of participants in a group who have no infection (zero eggs per gram of stool) four weeks after treatment at baseline
Outcome measures
| Measure |
Praziquantel 80 mg/kg Dose Only Baseline Treatment
n=84 Participants
75 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose at Baseline and 6 Months
n=80 Participants
75 children will receive 40 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose at Baseline and 6 Months
n=87 Participants
75 children will receive 80 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose Only Baseline Treatment
n=88 Participants
75 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
|---|---|---|---|---|
|
Treatment Efficacy - Cure Rate
|
90 Percent of participants
|
67 Percent of participants
|
90 Percent of participants
|
67 Percent of participants
|
SECONDARY outcome
Timeframe: 12 months following treatment at enrollment/baselinePopulation: subjects present for close out at 12 months
Assess impact of varying doses and frequency of dosing on hemoglobin measured 12 months after baseline treatment
Outcome measures
| Measure |
Praziquantel 80 mg/kg Dose Only Baseline Treatment
n=80 Participants
75 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose at Baseline and 6 Months
n=72 Participants
75 children will receive 40 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose at Baseline and 6 Months
n=72 Participants
75 children will receive 80 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose Only Baseline Treatment
n=72 Participants
75 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
|---|---|---|---|---|
|
Hemoglobin
|
10.3 grams/decilter
Standard Deviation 1.4
|
10.4 grams/decilter
Standard Deviation 1.3
|
10.4 grams/decilter
Standard Deviation 1.3
|
10.3 grams/decilter
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 12 months following treatment at enrollment/baselinePopulation: Subjects present at study close out at 12 months
Assess impact of varying doses and frequency of dosing on linear growth as captured by Z-score. A Z-score is the standard deviation from age (months) and sex mean from the World Health Organization's (WHO) Multicentre Growth Reference Study which derived the WHO "Anthro" reference. That reference assessed approximately 8500 children from widely different ethnic backgrounds and cultural settings (Brazil, Ghana, India, Norway, Oman and the USA) and provides a single international standard that represents the best description of physiological growth for all children from birth to five years of age and to establish the breastfed infant as the normative model for growth and development. For Z-scores presented, 0 represents the population mean for the healthy Anthro reference curve and positive values are taller children while negative are shorter. A Z score of -2.0 or below defines "stunting" or children -2 standard deviations below this healthy reference population.
Outcome measures
| Measure |
Praziquantel 80 mg/kg Dose Only Baseline Treatment
n=80 Participants
75 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose at Baseline and 6 Months
n=72 Participants
75 children will receive 40 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose at Baseline and 6 Months
n=72 Participants
75 children will receive 80 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose Only Baseline Treatment
n=72 Participants
75 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
|---|---|---|---|---|
|
Age and Gender Adjusted Linear Growth
|
-0.7 Z score
Standard Deviation 1.3
|
-0.8 Z score
Standard Deviation 1.4
|
-0.7 Z score
Standard Deviation 1.3
|
-0.8 Z score
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 12 months following treatment at enrollment/baselinePopulation: Weight for height z score (WHZ) at 12 months
Assess impact of varying doses and frequency of dosing on nutritional as captured by weight for height Z-score. A Z-score is the standard deviation from age (months) and sex mean from the World Health Organization's (WHO) Multicentre Growth Reference Study which derived the WHO "Anthro" reference. That reference assessed approximately 8500 children from widely different ethnic backgrounds and cultural settings (Brazil, Ghana, India, Norway, Oman and the USA) and provides a single international standard that represents the best description of physiological growth for all children from birth to five years of age and to establish the breastfed infant as the normative model for growth and development. For Z-scores presented, 0 represents the population mean for the healthy Anthro reference curve and positive values are better nourished children. A Z score of -2.0 or below defines "wasting" or children -2 standard deviations below mean of health reference
Outcome measures
| Measure |
Praziquantel 80 mg/kg Dose Only Baseline Treatment
n=80 Participants
75 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose at Baseline and 6 Months
n=80 Participants
75 children will receive 40 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose at Baseline and 6 Months
n=83 Participants
75 children will receive 80 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose Only Baseline Treatment
n=82 Participants
75 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
|---|---|---|---|---|
|
Age and Gender Adjusted Nutritional Status
|
0.4 Z score
Standard Deviation 0.9
|
0.3 Z score
Standard Deviation 0.9
|
0.4 Z score
Standard Deviation 0.9
|
0.3 Z score
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 12 months following treatment at enrollment/baselinePopulation: Calprotectin about 50 ug/g 12 months post baseline
A measure of gut inflammation that is measured on stool samples and captures intestinal inflammation largely caused by neutrophils that migrate to the gut
Outcome measures
| Measure |
Praziquantel 80 mg/kg Dose Only Baseline Treatment
n=80 Participants
75 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose at Baseline and 6 Months
n=80 Participants
75 children will receive 40 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose at Baseline and 6 Months
n=83 Participants
75 children will receive 80 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose Only Baseline Treatment
n=82 Participants
75 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
|---|---|---|---|---|
|
Fecal Calprotectin
|
29 percentage with calprotectin >50 ug/g
|
46 percentage with calprotectin >50 ug/g
|
29 percentage with calprotectin >50 ug/g
|
46 percentage with calprotectin >50 ug/g
|
Adverse Events
Praziquantel 40 mg/kg Dose Only Baseline Treatment
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Praziquantel 80 mg/kg Dose Only Baseline Treatment
Serious events: 1 serious events
Other events: 8 other events
Deaths: 1 deaths
Praziquantel 40 mg/kg Dose at Baseline and 6 Months
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Praziquantel 80 mg/kg Dose at Baseline and 6 Months
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Praziquantel 40 mg/kg Dose Only Baseline Treatment
n=88 participants at risk
75 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose Only Baseline Treatment
n=86 participants at risk
75 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose at Baseline and 6 Months
n=89 participants at risk
75 children will receive 40 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose at Baseline and 6 Months
n=91 participants at risk
75 children will receive 80 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
malaria
|
0.00%
0/88 • For one year during the 12 months following the first treatment at Baseline
Adverse events and serious adverse events were actively ascertained for 18 hours after dosing of the study agent at baseline. Serious adverse events were ascertained by report of family members following the dosing follow up window for up to one year (study participation time)
|
1.2%
1/86 • Number of events 1 • For one year during the 12 months following the first treatment at Baseline
Adverse events and serious adverse events were actively ascertained for 18 hours after dosing of the study agent at baseline. Serious adverse events were ascertained by report of family members following the dosing follow up window for up to one year (study participation time)
|
0.00%
0/89 • For one year during the 12 months following the first treatment at Baseline
Adverse events and serious adverse events were actively ascertained for 18 hours after dosing of the study agent at baseline. Serious adverse events were ascertained by report of family members following the dosing follow up window for up to one year (study participation time)
|
0.00%
0/91 • For one year during the 12 months following the first treatment at Baseline
Adverse events and serious adverse events were actively ascertained for 18 hours after dosing of the study agent at baseline. Serious adverse events were ascertained by report of family members following the dosing follow up window for up to one year (study participation time)
|
Other adverse events
| Measure |
Praziquantel 40 mg/kg Dose Only Baseline Treatment
n=88 participants at risk
75 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose Only Baseline Treatment
n=86 participants at risk
75 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 40 mg/kg Dose at Baseline and 6 Months
n=89 participants at risk
75 children will receive 40 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
Praziquantel 80 mg/kg Dose at Baseline and 6 Months
n=91 participants at risk
75 children will receive 80 mg/kg Praziquantel at baseline and again six months later.
Praziquantel: Praziquantel given as crushed tablets (40 or 80 mg/kg)
|
|---|---|---|---|---|
|
Hepatobiliary disorders
liver function tests
|
10.2%
9/88 • Number of events 9 • For one year during the 12 months following the first treatment at Baseline
Adverse events and serious adverse events were actively ascertained for 18 hours after dosing of the study agent at baseline. Serious adverse events were ascertained by report of family members following the dosing follow up window for up to one year (study participation time)
|
9.3%
8/86 • Number of events 8 • For one year during the 12 months following the first treatment at Baseline
Adverse events and serious adverse events were actively ascertained for 18 hours after dosing of the study agent at baseline. Serious adverse events were ascertained by report of family members following the dosing follow up window for up to one year (study participation time)
|
11.2%
10/89 • Number of events 10 • For one year during the 12 months following the first treatment at Baseline
Adverse events and serious adverse events were actively ascertained for 18 hours after dosing of the study agent at baseline. Serious adverse events were ascertained by report of family members following the dosing follow up window for up to one year (study participation time)
|
8.8%
8/91 • Number of events 8 • For one year during the 12 months following the first treatment at Baseline
Adverse events and serious adverse events were actively ascertained for 18 hours after dosing of the study agent at baseline. Serious adverse events were ascertained by report of family members following the dosing follow up window for up to one year (study participation time)
|
Additional Information
Dr. Jennifer Friedman
Center for International Health Research at Brown Health
Phone: 401 444 7990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place