GIARDIASISPhase 4NCT02942485
Treatment of Giardia Lamblia Infections in Children
A Phase 4 study testing Metronidazole and Tinidazole in people with GIARDIASIS, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- GIARDIASIS
- What is being tested?
- Metronidazole and Tinidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFinland
- Study dates
- 1 Dec 2016to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical symptoms could be explained by giardiasis AND
- fecal samples will test positive for the presence of G.lamblia in Uusimaa laboratory (HUSLAB)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Giardia Lamblia Infections in Children: Randomized Open-labeled Trial Comparing Rectal Metronidazole With Oral Tinidazole
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.
Read the 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.
- Conditions
- GIARDIASIS
- Being tested
- Metronidazole, Tinidazole
- Medical subject headings
- Giardiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetronidazoleDrug
Also called Flagyl
P/r suppositories
TinidazoleDrug
Also called Fasigyn
P/o tablets
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole | Experimental | 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. Receives: Drug: Metronidazole |
| Tinidazole | Active comparator | Patients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose Receives: Drug: Tinidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary outcomes (2)
Number of Participants With Side-effects
Will be assessed using structured questionnaire by interviewing parents/caregivers.
Measured: 10 days
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start1 Dec 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Extremely slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GIARDIASISStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svetlana Kostjukovits, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942485
- Sponsor's protocol ID
- PGLIT2016
- Status last verified
- Nov 2020
- First submitted
- 19 Oct 2016
- Last updated
- 18 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Giardia Lamblia Infections in Children: Randomized Open-labeled Trial Comparing Rectal Metronidazole With Oral Tinidazole
- ClinicalTrials.gov ID
- NCT02942485
- Acronym / sponsor ID
- PGLIT2016
- Conditions
- GIARDIASIS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Extremely slow enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Posted 18 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole | Experimental | Drug: MetronidazolePatients 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. |
| Tinidazole | Active comparator | Drug: TinidazolePatients will be treated with a standard regimen of oral tinidazole (Fasigyn) at a single dose of 50 mg/kg, maximum 2 g/dose |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- clinical symptoms could be explained by giardiasis AND
- fecal samples will test positive for the presence of G.lamblia in Uusimaa laboratory (HUSLAB)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetronidazoleAlso: FlagylP/r suppositories | Drug | Metronidazole |
| TinidazoleAlso: FasigynP/o tablets | Drug | Tinidazole |
Primary outcome
Clinical Recovery
Time frame: 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.
2 secondary outcomes
Number of Participants With Side-effects
Time frame: 10 days
Number of Participants With Negative G.Lamblia Antigen Test
Time frame: 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole and Tinidazole in people with GIARDIASIS, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Recovery (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.