Helminth InfectionPhase 4NCT03032042
Intestinal Microbiome Post-Azythromycin/Albendazole Treatment
A Phase 4 study testing Azithromycin, Albendazole and Delayed treatment in people with Helminth Infection, run by University of California, San Francisco at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Helminth Infection
- What is being tested?
- Azithromycin, Albendazole and Delayed treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEthiopia
- Study dates
- Jan 2017to Feb 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- all children 0 to 5 (up to 6th birthday)
Who cannot join
- individuals with a macrolide allergy
- refusal of parent/guardian
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Azithromycin, Albendazole, Delayed treatment
- Keywords
- intestinal microbiome, soil-transmitted helminths, mass drug administration
- Medical subject headings
- Trematode Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
AlbendazoleDrug
Delayed treatmentDrug
Albendazole+Azithromycin
| Study group | Role | What they receive |
|---|---|---|
| albendazole at day 0, azithromycin at day 7 | Experimental | Not described Receives: Drug: Albendazole |
| azithromycin at day 0, albendazole at day 7 | Experimental | Not described Receives: Drug: Azithromycin |
| albendazole at day 0, azithromycin at day 0 | Experimental | Not described Receives: Drug: Azithromycin; Drug: Albendazole |
| Delayed treatment | Other | albendazole at day 7, azithromycin at day 7 Receives: Drug: Delayed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 7
Secondary outcomes (1)
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.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJan 2017 (estimated)
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2018 (estimated)
Why it stopped: We were not able to secure IRB approval in the timeline necessary to do this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helminth InfectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Keenan, MD, MPH, Principal investigator, F.I. Proctor Foundation, University of California San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032042
- Sponsor's protocol ID
- 17-0101
- Status last verified
- Jun 2021
- First submitted
- 8 Jan 2017
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiome Post-Azythromycin/Albendazole Treatment
- ClinicalTrials.gov ID
- NCT03032042
- Acronym / sponsor ID
- 17-0101
- Conditions
- Helminth Infection
- Keywords
- intestinal microbiome, soil-transmitted helminths, mass drug administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were not able to secure IRB approval in the timeline necessary to do this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2017 (estimated)
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Delayed treatmentalbendazole at day 7, azithromycin at day 7 |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all children 0 to 5 (up to 6th birthday)
Key exclusion criteria (2 listed)
- individuals with a macrolide allergy
- refusal of parent/guardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 treatmentAlbendazole+Azithromycin | Drug | Delayed treatment |
Primary outcome
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
1 secondary outcome
Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5
Time frame: Day 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Keenan, MD, MPH principal investigator
F.I. Proctor Foundation, University of California San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin, Albendazole and Delayed treatment in people with Helminth Infection, run by University of California, San Francisco at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial diversity in the intestinal microbiomes of children aged 1-60 months (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.