Trial Outcomes & Findings for Treatment of Giardia Lamblia Infections in Children (NCT NCT02942485)
NCT ID: NCT02942485
Last Updated: 2020-11-18
Results Overview
Clinical recovery was defined as the resolution of symptoms by day 10 post-treatment, assessed using a structured questionnaire by interviewing the parents/caregivers.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
8 participants
Primary outcome timeframe
10 days
Results posted on
2020-11-18
Participant Flow
There were no cross-over patients.
Participant milestones
| Measure |
Metronidazole
Patients will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days.
Metronidazole: P/r suppositories
|
Tinidazole
Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose
Tinidazole: P/o tablets
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
1
|
|
Overall Study
COMPLETED
|
6
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Metronidazole
Patients will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days.
Metronidazole: P/r suppositories
|
Tinidazole
Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose
Tinidazole: P/o tablets
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Metronidazole
n=7 Participants
Patients will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days.
Metronidazole: P/r suppositories
|
Tinidazole
n=1 Participants
Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose
Tinidazole: P/o tablets
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=7 Participants
|
1 Participants
n=1 Participants
|
8 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=7 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=7 Participants
|
1 Participants
n=1 Participants
|
7 Participants
n=8 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 10 daysPopulation: 3 participants in the "Metronidazole" and 1 participant "Tinidazole" Arm/Group were asymptomatic and the main primary outcome (clinical cure) could not be assessed
Clinical recovery was defined as the resolution of symptoms by day 10 post-treatment, assessed using a structured questionnaire by interviewing the parents/caregivers.
Outcome measures
| Measure |
Metronidazole
n=4 Participants
Patients will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days.
Metronidazole: P/r suppositories
|
Tinidazole
Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose
Tinidazole: P/o tablets
|
|---|---|---|
|
Clinical Recovery
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 10 daysWill be assessed using structured questionnaire by interviewing parents/caregivers.
Outcome measures
| Measure |
Metronidazole
n=7 Participants
Patients will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days.
Metronidazole: P/r suppositories
|
Tinidazole
n=1 Participants
Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose
Tinidazole: P/o tablets
|
|---|---|---|
|
Number of Participants With Side-effects
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 10 daysMicrobiological recovery was defined as negative G.lamblia antigen test from fecal samples collected on day 10 post-treatment.
Outcome measures
| Measure |
Metronidazole
n=5 Participants
Patients will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days.
Metronidazole: P/r suppositories
|
Tinidazole
n=1 Participants
Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose
Tinidazole: P/o tablets
|
|---|---|---|
|
Number of Participants With Negative G.Lamblia Antigen Test
|
5 Participants
|
1 Participants
|
Adverse Events
Metronidazole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Tinidazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metronidazole
n=7 participants at risk
Patients will be given rectal metronidazole (Flagyl) 500 mg/dose for children weighing 10-14,9 kg, 1000 mg/dose for those weighing 15-29,9 kg and 1500 mg/dose for those weighing 30-44,9 kg. Suppositories will not be halved. Patients will be given 1 dose/day for 3 days.
Metronidazole: P/r suppositories
|
Tinidazole
n=1 participants at risk
Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose
Tinidazole: P/o tablets
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
14.3%
1/7 • Number of events 1 • 1 month
All healthy children
|
0.00%
0/1 • 1 month
All healthy children
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place