Safety and efficacy of rectally administered metronidazole for the treatment of Giardia lamblia infections in children

Treatment of Giardia lamblia infections in children: randomized open-labeled trial comparing rectal metronidazole with oral tinidazole

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001938-96-FI

Enrollment

180

Registered

2016-10-28

Start date

2016-12-22

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Giardia lamblia infections in children

Interventions

Trade Name: Flagyl Product Name: Flagyl Pharmaceutical Form: Vaginal capsule INN or Proposed INN: METRONIDAZOLE Trade Name: Fasigyn Product Name: Fasigyn Pharmaceutical Form: Tablet Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children aged 6 months to 10 years whose clinical symptoms could be explained by giardiasis and whose fecal samples will test positive for the presence of Giardia lamblia in Uusimaa laboratory (HUSLAB). Are the trial subjects under 18? yes Number of subjects for this age range: 180 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) age 10 years, 2) weight <9.5 kg, 3) the absence of symptoms, 4) co-infection with another pathogen, which may cause giardiasis-like symptoms.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate safety and efficacy of rectally administered metronidazole in the treatment of Giardia lamblia infections in children;Secondary Objective: Not applicable;Primary end point(s): Clinical and / or microbiological cure. Criteria for clinical cure will be resolution of symptoms by day 10 and microbiological cure will be defined as negative Giardia lamblia antigen test from fecal samples collected on day 7-10 post-treatment.;Timepoint(s) of evaluation of this end point: Day 10 post-treatment	—

Measure

Time frame

Main Objective: To investigate safety and efficacy of rectally administered metronidazole in the treatment of Giardia lamblia infections in children;Secondary Objective: Not applicable;Primary end point(s): Clinical and / or microbiological cure. Criteria for clinical cure will be resolution of symptoms by day 10 and microbiological cure will be defined as negative Giardia lamblia antigen test from fecal samples collected on day 7-10 post-treatment.;Timepoint(s) of evaluation of this end point: Day 10 post-treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of possible side-effects of treatment.;Timepoint(s) of evaluation of this end point: Within 1 month of treatment	—

Countries

Finland

Contacts

Public ContactChildren's Hospital

Helsinki University Central Hospital

358094711

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026