Cystic FibrosisMUCOPHAGESNCT01818206
Bacteriophage Effects on Pseudomonas Aeruginosa
A study testing Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages. in people with Cystic Fibrosis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been investigated in animals. The aim of the present study is to evaluate the efficacy of bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Apr 2012
- Phase
- Interventional
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent
- Affiliated or benefit from a disease insurance regimen
- Men and women
- Aged from at least 6 years old
- Confirmed Diagnosis of cystic fibrosis based on presence of 2 mutations of CFTR gene and/or 2 positive tests of sweat chloride and/or 2 measures of pathologic difference of nasal potential associated to cystic fibrosis clinical signs.
- Patients able to produce sputum
- Pseudomonas aeruginosa Chronic infected patients
Who cannot join
- Simultaneous participation to another project on anti-infection, anti-inflammatory or modificating agents
- Subjet in exclusion period
- Law protected patient
- Realisation of sputum production is contra-indicated
Trial locations and contacts
1 site in 1 country.
France1 site
CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM
Montpellier, Languedoc Roussillon, 34295
About this study
Official title: Bacteriophages Effects on Pseudomonas Aeruginosa Presents in Sputum of Cystic Fibrosis (CF) Patients
Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been investigated in animals. The aim of the present study is to evaluate the efficacy of bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. A cocktail of 10 bacteriophages will be applied on 60 sputum samples obtained from cystic fibrosis (CF) patients during 6 hours.We will determine the bacteria and bacteriophages strains in sputum samples collected. Then the sensitivity of individual colony will be tested.
- Conditions
- Cystic Fibrosis
- Being tested
- Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.
- Keywords
- Cystic Fibrosis, Bacteriophages, Pseudomonas aeruginosa, Sputum
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.Other
Collection of induced sputum on cystic fibrosis patients in order to evaluate the efficacy of a cocktail of 10 bacteriophages.
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis (CF) patients | Experimental | Cystic fibrosis patients whom induced sputum is collected in order to evaluate the efficacy of a cocktail of 10 bacteriophages. Receives: Other: Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage
Measured: after 6 hours in presence of bacteriophage
Secondary outcomes (3)
Pseudomonas aeruginosa (PA) strains counts after 24 hours in presence of bacteriophage
Measured: after 24 hours in presence of bacteriophage
Bacteriophage counts after 6 hours incubation within sputum samples
Measured: after 6 hours incubation within sputum samples
Sensitivity of individual Pseudomonas aeruginosa (PA) colonies to bacteriophages
Measured: Sensitivity of individual PA colonies to bacteriophages
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphaël RC CHIRON, RC, Principal investigator, CHU de Montpellier - Hôpital Arnaud de Villeneuve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818206
- Sponsor's protocol ID
- UF 8750
- Acronym
- MUCOPHAGES
- Status last verified
- Sep 2013
- First submitted
- 21 Mar 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriophages Effects on Pseudomonas Aeruginosa Presents in Sputum of Cystic Fibrosis (CF) Patients
- ClinicalTrials.gov ID
- NCT01818206
- Acronym / sponsor ID
- MUCOPHAGES / UF 8750
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Bacteriophages, Pseudomonas aeruginosa, Sputum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Mar 2013 (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.
Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been investigated in animals. The aim of the present study is to evaluate the efficacy of bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. A cocktail of 10 bacteriophages will be applied on 60 sputum samples obtained from cystic fibrosis (CF) patients during 6 hours.We will determine the bacteria and bacteriophages strains in sputum samples collected. Then the sensitivity of individual colony will be tested.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis (CF) patients | Experimental | Other: Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.Cystic fibrosis patients whom induced sputum is collected in order to evaluate the efficacy of a cocktail of 10 bacteriophages. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent
- Affiliated or benefit from a disease insurance regimen
- Men and women
- Aged from at least 6 years old
- Confirmed Diagnosis of cystic fibrosis based on presence of 2 mutations of CFTR gene and/or 2 positive tests of sweat chloride and/or 2 measures of pathologic difference of nasal potential associated to cystic fibrosis clinical signs.
Key exclusion criteria (4 listed)
- Simultaneous participation to another project on anti-infection, anti-inflammatory or modificating agents
- Subjet in exclusion period
- Law protected patient
- Realisation of sputum production is contra-indicated
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 |
|---|---|---|
| Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.Collection of induced sputum on cystic fibrosis patients in order to evaluate the efficacy of a cocktail of 10 bacteriophages. | Other | Cystic fibrosis (CF) patients |
Primary outcome
Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage
Time frame: after 6 hours in presence of bacteriophage
3 secondary outcomes
Pseudomonas aeruginosa (PA) strains counts after 24 hours in presence of bacteriophage
Time frame: after 24 hours in presence of bacteriophage
Bacteriophage counts after 6 hours incubation within sputum samples
Time frame: after 6 hours incubation within sputum samples
Sensitivity of individual Pseudomonas aeruginosa (PA) colonies to bacteriophages
Time frame: Sensitivity of individual PA colonies to bacteriophages
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 5 Sep 2013.
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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.
Raphaël RC CHIRON, RC principal investigator
CHU de Montpellier - Hôpital Arnaud de Villeneuve
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages. in people with Cystic Fibrosis, run by University Hospital, Montpellier at 1 site in France.
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 7 inclusion and 4 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 5 Sep 2013. 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 France. 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.
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?
Pseudomonas aeruginosa (PA) strains counts after 6 hours in presence of bacteriophage (time frame: after 6 hours in presence of bacteriophage). 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 5 Sep 2013.