Treatment of Giardia Lamblia Infections in Children

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.

Study Overview

• Status: Terminated
• Conditions: GIARDIASIS
• Intervention / Treatment: Drug: Metronidazole; Drug: 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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Children's Hospital, HYKS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Metronidazole; P/r suppositories; Other Names: Flagyl
Active Comparator: 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	Drug: Tinidazole; P/o tablets; Other Names: Fasigyn

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Side-effects	Will be assessed using structured questionnaire by interviewing parents/caregivers.	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.	10 days

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Diseases, Parasitic; Parasitic Diseases; Protozoan Infections; Giardiasis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Alkylating Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antitrichomonal Agents; Metronidazole; Tinidazole
• Other Study ID Numbers: PGLIT2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes