Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

NCT ID: NCT03032042

Last Updated: 2021-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Helminth Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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albendazole at day 0, azithromycin at day 7

Group Type EXPERIMENTAL

Albendazole

Intervention Type DRUG

azithromycin at day 0, albendazole at day 7

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

albendazole at day 0, azithromycin at day 0

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

Albendazole

Intervention Type DRUG

Delayed treatment

albendazole at day 7, azithromycin at day 7

Group Type OTHER

Delayed treatment

Intervention Type DRUG

Albendazole+Azithromycin

Interventions

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Azithromycin

Intervention Type DRUG

Albendazole

Intervention Type DRUG

Delayed treatment

Albendazole+Azithromycin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* individuals with a macrolide allergy
* refusal of parent/guardian
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeremy Keenan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

F.I. Proctor Foundation, University of California San Francisco

Locations

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The Carter Center Ethiopia

Addis Ababa, , Ethiopia

Site Status

Countries

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Ethiopia

Other Identifiers

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17-0101

Identifier Type: -

Identifier Source: org_study_id

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