Treatment of Giardia Lamblia Infections in Children

NCT02942485 | Terminated Phase 4 Results DMC

• 1 other identifier: PGLIT2016
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

GIARDIASIS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Side-effects

  10 days

• Number of Participants With Negative G.Lamblia Antigen Test

  10 days

Study Arms (2)

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.

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

Drug: Tinidazole

Interventions

Metronidazole DRUG

P/r suppositories

Also known as: Flagyl

Metronidazole

Tinidazole DRUG

P/o tablets

Also known as: Fasigyn

Tinidazole

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• clinical symptoms could be explained by giardiasis AND
• fecal samples will test positive for the presence of G.lamblia in Uusimaa laboratory (HUSLAB)

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Children's Hospital, HYKS

Helsinki, Finland

Location

MeSH Terms

Conditions

Giardiasis

Interventions

Metronidazole; Tinidazole

Condition Hierarchy (Ancestors)

Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was terminated due to the extremely slow patient enrollment: eight patients only have been referred and recruited during the two-year period. 6/8 patients fulfilled one or more of the exclusion criteria.

Results Point of Contact

• Title: Dr. Svetlana Vakkilainen
• Organization: University of Helsinki

svetlanakostjukovitch@gmail.com

+358407693375

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 24, 2016
• Study Start: December 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 18, 2020
• Results First Posted: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

FI (1)