Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

June 23, 2021 updated by: University of California, San Francisco
Molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond targeted PCR testing to next generation sequencing techniques. In addition, the current state of monitoring for soil-transmitted helminth infections is moving increasingly from microscopic techniques to molecular techniques. The targeted PCR test for soil transmitted helminth diagnosis has been validated on stool samples, but not rectal swabs. Bulk stool samples are logistically challenging and time-intensive to collect, thus participation is often far from optimal. Rectal swabs are more efficient and may result in higher participation. In this study, children will be randomized to either albendazole, azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be collected. The investigators will compare the PCR test for soil transmitted helminth infections using both the rectal swabs and the bulk stool samples. In addition, the investigators will analyze the gut microbiome of the children using next generation sequencing techniques to gain insight into effects of mass drug administration.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Addis Ababa, Ethiopia
        • The Carter Center Ethiopia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all children 0 to 5 (up to 6th birthday)

Exclusion Criteria:

  • individuals with a macrolide allergy
  • refusal of parent/guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: albendazole at day 0, azithromycin at day 7
Drug: Albendazole
Experimental: azithromycin at day 0, albendazole at day 7
Drug: Azithromycin
Experimental: albendazole at day 0, azithromycin at day 0
Drug: Azithromycin
Drug: Albendazole
Other: Delayed treatment
albendazole at day 7, azithromycin at day 7
Drug: Delayed treatment
Albendazole+Azithromycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbial diversity in the intestinal microbiomes of children aged 1-60 months
Time Frame: Day 7
Microbiota diversity in the intestinal microbiomes of children aged 1-60 months in azithromycin-treated, albendazole-treated, azithromycin+albendazole-treated and delayed treatment arms using phylogenetic distance measures
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5
Time Frame: Day 7
The investigators use PCR to identify soil transmitted helming infections in rectal swab samples and bulk stool sample from the same child. Using the bulk stool sample as the gold standard, the investigators will calculate the sensitivity, specificity, PPV, and NPV of the rectal swabs for detecting the various helminth infections.
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Jeremy Keenan, MD, MPH, F.I. Proctor Foundation, University of California San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2017

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

January 8, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimate)

January 26, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 23, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-0101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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