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Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

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: NCT03032042
Recruitment Status : Withdrawn (We were not able to secure IRB approval in the timeline necessary to do this study.)
First Posted : January 26, 2017
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Jeremy Keenan, Francis I. Proctor Foundation

Tracking Information
First Submitted Date  ICMJE January 8, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date May 14, 2020
Estimated Study Start Date  ICMJE January 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intestinal Microbiome Post-Azythromycin/Albendazole Treatment
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Helminth Infection
Intervention  ICMJE
  • Drug: Azithromycin
  • Drug: Albendazole
  • Drug: Delayed treatment
    Albendazole+Azithromycin
Study Arms  ICMJE
  • Experimental: albendazole at day 0, azithromycin at day 7
    Intervention: Drug: Albendazole
  • Experimental: azithromycin at day 0, albendazole at day 7
    Intervention: Drug: Azithromycin
  • Experimental: albendazole at day 0, azithromycin at day 0
    Interventions:
    • Drug: Azithromycin
    • Drug: Albendazole
  • Delayed treatment
    albendazole at day 7, azithromycin at day 7
    Intervention: Drug: Delayed treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 13, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
100
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • individuals with a macrolide allergy
  • refusal of parent/guardian
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ethiopia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032042
Other Study ID Numbers  ICMJE 17-0101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeremy Keenan, Francis I. Proctor Foundation
Study Sponsor  ICMJE Francis I. Proctor Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeremy Keenan, MD, MPH F.I. Proctor Foundation, University of California San Francisco
PRS Account Francis I. Proctor Foundation
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP