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Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

Primary Purpose

Helminth Infection

Status
Withdrawn
Phase
Phase 4
Locations
Ethiopia
Study Type
Interventional
Intervention
Azithromycin
Albendazole
Delayed treatment
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Helminth Infection focused on measuring intestinal microbiome, soil-transmitted helminths, mass drug administration

Eligibility Criteria

undefined - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • The Carter Center Ethiopia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

albendazole at day 0, azithromycin at day 7

azithromycin at day 0, albendazole at day 7

albendazole at day 0, azithromycin at day 0

Delayed treatment

Arm Description

albendazole at day 7, azithromycin at day 7

Outcomes

Primary Outcome Measures

Microbial diversity in the intestinal microbiomes of children aged 1-60 months
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

Secondary Outcome Measures

Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5
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.

Full Information

First Posted
January 8, 2017
Last Updated
June 23, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03032042
Brief Title
Intestinal Microbiome Post-Azythromycin/Albendazole Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
We were not able to secure IRB approval in the timeline necessary to do this study.
Study Start Date
January 2017 (Anticipated)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helminth Infection
Keywords
intestinal microbiome, soil-transmitted helminths, mass drug administration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
albendazole at day 0, azithromycin at day 7
Arm Type
Experimental
Arm Title
azithromycin at day 0, albendazole at day 7
Arm Type
Experimental
Arm Title
albendazole at day 0, azithromycin at day 0
Arm Type
Experimental
Arm Title
Delayed treatment
Arm Type
Other
Arm Description
albendazole at day 7, azithromycin at day 7
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Type
Drug
Intervention Name(s)
Delayed treatment
Intervention Description
Albendazole+Azithromycin
Primary Outcome Measure Information:
Title
Microbial diversity in the intestinal microbiomes of children aged 1-60 months
Description
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
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5
Description
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.
Time Frame
Day 7

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all children 0 to 5 (up to 6th birthday) Exclusion Criteria: individuals with a macrolide allergy refusal of parent/guardian
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Keenan, MD, MPH
Organizational Affiliation
F.I. Proctor Foundation, University of California San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Carter Center Ethiopia
City
Addis Ababa
Country
Ethiopia

12. IPD Sharing Statement

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Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

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