Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

NCT03032042 | Withdrawn Phase 4 DMC

• 1 other identifier: 17-0101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Helminth Infection

Keywords

intestinal microbiome; soil-transmitted helminths; mass drug administration

Outcome Measures

Primary Outcomes (1)

• 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

  Day 7

Secondary Outcomes (1)

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

  Day 7

Study Arms (4)

albendazole at day 0, azithromycin at day 7

EXPERIMENTAL

Drug: Albendazole

azithromycin at day 0, albendazole at day 7

EXPERIMENTAL

Drug: Azithromycin

albendazole at day 0, azithromycin at day 0

EXPERIMENTAL

Drug: Azithromycin; Drug: Albendazole

Delayed treatment

OTHER

albendazole at day 7, azithromycin at day 7

Drug: Delayed treatment

Interventions

Azithromycin DRUG

albendazole at day 0, azithromycin at day 0; azithromycin at day 0, albendazole at day 7

Albendazole DRUG

albendazole at day 0, azithromycin at day 0; albendazole at day 0, azithromycin at day 7

Delayed treatment DRUG

Albendazole+Azithromycin

Delayed treatment

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

The Carter Center Ethiopia

Addis Ababa, Ethiopia

Location

MeSH Terms

Conditions

Trematode Infections

Interventions

Azithromycin; Albendazole; Treatment Delay

Condition Hierarchy (Ancestors)

Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Time-to-Treatment; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jeremy Keenan, MD, MPH

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2017
• First Posted: January 26, 2017
• Study Start: January 1, 2017
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2018
• Last Updated: June 28, 2021

Record last verified: 2021-06

Locations

ET (1)