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Treatment of Giardia Lamblia Infections in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02942485
Recruitment Status : Terminated (Extremely slow enrollment)
First Posted : October 24, 2016
Results First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Svetlana Kostjukovits, Helsinki University Central Hospital

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.

Condition or disease Intervention/treatment Phase
GIARDIASIS Drug: Metronidazole Drug: Tinidazole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Giardia Lamblia Infections in Children: Randomized Open-labeled Trial Comparing Rectal Metronidazole With Oral Tinidazole
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Fasigyn




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of Participants With Side-effects [ Time Frame: 10 days ]
    Will be assessed using structured questionnaire by interviewing parents/caregivers.

  2. Number of Participants With Negative G.Lamblia Antigen Test [ Time Frame: 10 days ]
    Microbiological recovery was defined as negative G.lamblia antigen test from fecal samples collected on day 10 post-treatment.



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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942485


Locations
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Finland
Children's Hospital, HYKS
Helsinki, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
  Study Documents (Full-Text)

Documents provided by Svetlana Kostjukovits, Helsinki University Central Hospital:
Study Protocol  [PDF] September 1, 2016
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: Svetlana Kostjukovits, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02942485    
Other Study ID Numbers: PGLIT2016
First Posted: October 24, 2016    Key Record Dates
Results First Posted: November 18, 2020
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Giardiasis
Infections
Intestinal Diseases, Parasitic
Parasitic Diseases
Protozoan Infections
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metronidazole
Tinidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antitrichomonal Agents