Antibiotic Resistant BacteriaPhase 4ANTIRESDEVNCT02030912

Effect of Minocycline & Amoxicillin on Antibiotic Resistant Bacteria and Indigenous Microbiotas

A Phase 4 study testing 3 doses of amoxicillin daily for 7 days and 2 doses of minocycline daily for five days in people with Antibiotic Resistant Bacteria, run by Helperby Therapeutics Ltd at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Antibiotic Resistant Bacteria
What is being tested?: 3 doses of amoxicillin daily for 7 days and 2 doses of minocycline daily for five days
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteUnited Kingdom
Study dates: Dec 2009to Dec 2013
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 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Men and women aged between 18 and 40 years.
Following verbal \& written information about the trial, the subject has signed \& dated informed consent before any study related activity was carried out.
Subject legally competent and able to communicate effectively with the study personnel
Normal finding in the medical history and physical examination, unless the investigator considers an abnormality to be clinically irrelevant.
Male or female subjects who are using a medically acceptable method of contraception or of non-childbearing potential (i.e., surgically sterile-bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing or naturally postmenopausal for at least one year with a Screening FSH leve≥l 40 mIU/L). - - A negative serum pregnancy test is required at Screening for females.

Who cannot join

Regular use of medication, except contraceptive, vitamin tablets, treatment with antimicrobial agents within the 3 months preceding the study, Use of antibiotics for 4 weeks prior to the study drug application or use of concomitant systemic or topical antibiotics, Systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to baseline visit (Visit 2) .
Participation in a trial with another investigational drug within the 3 months preceding the study
Present or residual gastrointestinal, renal insufficiency or hepatic disorder
Abnormal pathology of nasal passages
Any clinically significant allergy or drug intolerance
Active hay fever, on-going cold/flu symptoms, including rhinitis at baseline (visit 2)

Show all 12Show fewer

Any medical history of renal insufficiency or hepatic disorder or other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
history of hypersensitivity to beta-lactams or tetracycline
pregnant or breast-feeding women
Subjects known or suspected of not being able to comply with trial protocol (e.g. alcoholism, drug dependency, or psychological state). History of regular alcohol consumption exceeding an average weekly intake of alcohol greater than 21 units for female and 28 units for male.
One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine.
Subjects with known or suspected immunodeficiency.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Richmond Pharmacology Ltd
London, London, SW17 0RE,

Other trials in United Kingdom

About this study

Official title: Phase 4 Study Into the Effect of Minocycline and Amoxicillin Administration of the Prevalence of Antibiotic Resistant Bacteria and on the Indigenous Oral, Faecal, Cutaneous and Nasal Microbiotas

A randomised, open labelled study design is selected in order to determine the emergence and persistence of antibiotic resistant bacteria in humans and on the composition of the indigenous microbiotas at various body sites. These will involve the administration to volunteers of minocycline and amoxicillin- a control group will receive a placebo. Microbiology of the skin, saliva, faecal, skin and nasal micro flora, safety and adverse events, vital signs, will be evaluated. The objectives of metagenomic analysis are:

To identify the in vivo molecular mechanisms responsible for antibiotic resistance and its transfer in the indigenous oral and faecal microbiotas using metagenomics resistome analysis.
To determine the impact of the use of antimicrobial agents on the oral resistome
To determine the impact of the use of antimicrobial agents on the faecal resistome
To determine the ecological impact of the use of antimicrobial agents on the relative abundance of phylotypes of the indigenous oral microbiota
To determine the ecological impact of the use of antimicrobial agents on the relative abundance of phylotypes of the indigenous faecal microbiotas

Conditions: Antibiotic Resistant Bacteria
Being tested: 3 doses of amoxicillin daily for 7 days, 2 doses of minocycline daily for five days, 2 doses of placebo daily for five days
Keywords: The impact of a number of different types of antibiotics, The emergence and persistence of antibiotic resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3 doses of amoxicillin daily for 7 daysDrug
2 doses of minocycline daily for five daysDrug
2 doses of placebo daily for five daysOther

Study groups in NCT02030912
Study group	Role	What they receive
3 doses of amoxicillin daily for 7 days	Active comparator	Cohort A: 3 doses of amoxicillin daily for 7 days (n=14). Follow up 12 months. Receives: Drug: 3 doses of amoxicillin daily for 7 days
2 doses of minocycline daily for 5 days	Active comparator	Cohort B: 2 doses of minocycline daily for five days (n=14). Follow up 12 months. Receives: Drug: 2 doses of minocycline daily for five days
2 doses of placebo daily for 5 days	Placebo comparator	Cohort C: 2 doses of placebo daily for five days (n=14). Follow up 12 months. Receives: Other: 2 doses of placebo daily for five days

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of resistant bacteria collected from body sites in subjects receiving minocycline/ amoxicillin compared to the baseline.
Measured: 12 Months

Secondary outcomes (1)

Adverse events (AEs) will be monitored throughout the study
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Dec 2013

First posted9 Jan 2014 (estimated)
Study startDec 2009
Primary completionDec 2012
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Antibiotic Resistant BacteriaStudies of the same condition, open and under way.
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: Health services research
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02030912
Sponsor's protocol ID: C09040
Acronym: ANTIRESDEV
Status last verified: Jan 2014
First submitted: 7 Jan 2014
Last updated: 9 Jan 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingObservational study
Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria
Critically-ill Patients
Enrolling by invitation
Effects of Three Oral Hygiene Protocols on Oral Bacteria in Intensive Care Patients
Oral Bacterial Colonization, Oral Hygiene
Not yet recruitingPhase 4
Tobramycin Nebulization to Prevent Multidrug-Resistant Ventilator-Associated Pneumonia
Pneumonia, Ventilator-Associated
Recruiting
Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients
Bloodstream Infection, Gram Negative Infections

All Antibiotic Resistant Bacteria trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Study Into the Effect of Minocycline and Amoxicillin Administration of the Prevalence of Antibiotic Resistant Bacteria and on the Indigenous Oral, Faecal, Cutaneous and Nasal Microbiotas
ClinicalTrials.gov ID: NCT02030912
Acronym / sponsor ID: ANTIRESDEV / C09040
Conditions: Antibiotic Resistant Bacteria
Keywords: The impact of a number of different types of antibiotics, The emergence and persistence of antibiotic resistance
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Helperby Therapeutics LtdIndustry (pharma, biotech, devices)
Collaborators: Richmond Pharmacology Limited
Study start: Dec 2009
Primary completion: Dec 2012 (actual)
Study completion: Dec 2013 (actual)
First posted: 9 Jan 2014 (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.

To identify the in vivo molecular mechanisms responsible for antibiotic resistance and its transfer in the indigenous oral and faecal microbiotas using metagenomics resistome analysis.
To determine the impact of the use of antimicrobial agents on the oral resistome
To determine the impact of the use of antimicrobial agents on the faecal resistome
To determine the ecological impact of the use of antimicrobial agents on the relative abundance of phylotypes of the indigenous oral microbiota
To determine the ecological impact of the use of antimicrobial agents on the relative abundance of phylotypes of the indigenous faecal microbiotas

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
3 doses of amoxicillin daily for 7 days	Active comparator	Drug: 3 doses of amoxicillin daily for 7 daysCohort A: 3 doses of amoxicillin daily for 7 days (n=14). Follow up 12 months.
2 doses of minocycline daily for 5 days	Active comparator	Drug: 2 doses of minocycline daily for five daysCohort B: 2 doses of minocycline daily for five days (n=14). Follow up 12 months.
2 doses of placebo daily for 5 days	Placebo comparator	Other: 2 doses of placebo daily for five daysCohort C: 2 doses of placebo daily for five days (n=14). Follow up 12 months.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Men and women aged between 18 and 40 years.
Following verbal \& written information about the trial, the subject has signed \& dated informed consent before any study related activity was carried out.
Subject legally competent and able to communicate effectively with the study personnel
Normal finding in the medical history and physical examination, unless the investigator considers an abnormality to be clinically irrelevant.
Male or female subjects who are using a medically acceptable method of contraception or of non-childbearing potential (i.e., surgically sterile-bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing or naturally postmenopausal for at least one year with a Screening FSH leve≥l 40 mIU/L). - - A negative serum pregnancy test is required at Screening for females.

Key exclusion criteria (12 listed)

Regular use of medication, except contraceptive, vitamin tablets, treatment with antimicrobial agents within the 3 months preceding the study, Use of antibiotics for 4 weeks prior to the study drug application or use of concomitant systemic or topical antibiotics, Systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to baseline visit (Visit 2) .
Participation in a trial with another investigational drug within the 3 months preceding the study
Present or residual gastrointestinal, renal insufficiency or hepatic disorder
Abnormal pathology of nasal passages
Any clinically significant allergy or drug intolerance

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
3 doses of amoxicillin daily for 7 days	Drug	3 doses of amoxicillin daily for 7 days
2 doses of minocycline daily for five days	Drug	2 doses of minocycline daily for 5 days
2 doses of placebo daily for five days	Other	2 doses of placebo daily for 5 days

Primary outcome

Percentage of resistant bacteria collected from body sites in subjects receiving minocycline/ amoxicillin compared to the baseline.
Time frame: 12 Months

1 secondary outcome

Adverse events (AEs) will be monitored throughout the study
Time frame: 12 Months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.

Related trials for Antibiotic Resistant Bacteria

Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
RecruitingObservational study
Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria
Critically-ill Patients
Enrolling by invitation
Effects of Three Oral Hygiene Protocols on Oral Bacteria in Intensive Care Patients
Oral Bacterial Colonization, Oral Hygiene
Not yet recruitingPhase 4
Tobramycin Nebulization to Prevent Multidrug-Resistant Ventilator-Associated Pneumonia
Pneumonia, Ventilator-Associated
Recruiting
Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients
Bloodstream Infection, Gram Negative Infections

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.

Jorg Taubel, MD principal investigator

Richmond Pharmacology Limited

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 12 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: finished, as of the sponsor's last update on 9 Jan 2014. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of resistant bacteria collected from body sites in subjects receiving minocycline/ amoxicillin compared to the baseline. (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02030912.

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 9 Jan 2014.