GIARDIASIS
Conditions
Brief summary
This study investigates the efficacy and safety of rectally administered metronidazole for pediatric Giardia lamblia infection, as well as the acceptance of this treatment regimen by patients/caregivers. The investigators hypothesize that rectal metronidazole is non-inferior to single-dose of oral tinidazole and will cure at least 72% of patients, a well as will be tolerated as good as tinidazole.
Detailed description
Approximately 180 children (age 6 months to 10 years) whose clinical symptoms could be explained by giardiasis and whose fecal samples will test positive for the presence of G.lamblia in Uusimaa laboratory (HUSLAB) will be recruited. The study will be performed as an open-label trial. Patients will be randomized during primary visits alternately into two groups by random allocation to receive either of the two study drugs. Patients from group 1 will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose. Patients from group 2 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. The first dose of metronidazole will be administered during the primary clinical visit and 2 additional doses will be provided to the parents for home administration. Fecal samples will be collected from the study patients on day 7-10 post-treatment and will be analyzed in HUSLAB for the presence of G.lamblia antigen by enzyme immunoassay (EIA). Early collection of samples on day 7-10 will help to avoid the risk of tests being positive due to reinfection. If any of the patients will not clear the infection by day 10, he/she will be invited to a second visit and re-treated. Patients from group 1 will be re-treated by rectal metronidazole and patients from group 2 by oral tinidazole, thus performing a cross-over. Follow-up stool samples will be collected. Criteria for clinical cure will be resolution of symptoms by day 10 and microbiological cure will be defined as negative G.lamblia antigen test from fecal samples collected on day 7-10 post-treatment.
Interventions
DRUGMetronidazole
P/r suppositories
DRUGTinidazole
P/o tablets
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
No
Inclusion criteria
* clinical symptoms could be explained by giardiasis AND * fecal samples will test positive for the presence of G.lamblia in Uusimaa laboratory (HUSLAB)
Exclusion criteria
* age \<6 mo or \>10 years * weight \<9.5 kg * the absence of symptoms * co-infection with another pathogen, which may cause giardiasis-like symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Recovery | 10 days | Clinical recovery was defined as the resolution of symptoms by day 10 post-treatment, assessed using a structured questionnaire by interviewing the parents/caregivers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Negative G.Lamblia Antigen Test | 10 days | Microbiological recovery was defined as negative G.lamblia antigen test from fecal samples collected on day 10 post-treatment. |
| Number of Participants With Side-effects | 10 days | Will be assessed using structured questionnaire by interviewing parents/caregivers. |
Countries
Finland
Participant flow
Recruitment details
There were no cross-over patients.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 1 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Metronidazole | Tinidazole | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 1 Participants | 8 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 1 |
| other Total, other adverse events | 1 / 7 | 0 / 1 |
| serious Total, serious adverse events | 0 / 7 | 0 / 1 |
Outcome results
Primary
Clinical Recovery
Clinical recovery was defined as the resolution of symptoms by day 10 post-treatment, assessed using a structured questionnaire by interviewing the parents/caregivers.
Time frame: 10 days
Population: 3 participants in the Metronidazole and 1 participant Tinidazole Arm/Group were asymptomatic and the main primary outcome (clinical cure) could not be assessed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metronidazole | Clinical Recovery | 4 Participants |
| Tinidazole | Clinical Recovery | 0 Participants |
Secondary
Number of Participants With Negative G.Lamblia Antigen Test
Microbiological recovery was defined as negative G.lamblia antigen test from fecal samples collected on day 10 post-treatment.
Time frame: 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metronidazole | Number of Participants With Negative G.Lamblia Antigen Test | 5 Participants |
| Tinidazole | Number of Participants With Negative G.Lamblia Antigen Test | 1 Participants |
Secondary
Number of Participants With Side-effects
Will be assessed using structured questionnaire by interviewing parents/caregivers.
Time frame: 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metronidazole | Number of Participants With Side-effects | 1 Participants |
| Tinidazole | Number of Participants With Side-effects | 0 Participants |