Pseudomonas AeruginosaNCT01616862
The Carrier Rates of Pseudomonas Aeruginosa in Family Members of Children With Cystic Fibrosis
An observational study of Pseudomonas Aeruginosa and Cystic Fibrosis, run by Zafer Soultan at 1 site in United States.
Trial summary
Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung infections in people with CF. Many young children do not have Pa in their lungs but will become infected as they get older. Read more about this study
- Who is it for?
- Ages 5 to 19 years
- Conditions the study is for
- Pseudomonas Aeruginosa, Cystic Fibrosis
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Aug 2013
- Phase
- Observational
- 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 5 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Biological parents of children with cystic fibrosis who are treated at Upstate Medical University. Children's age is more than 5 yrs and less than 20 yrs.
Who may be able to join
- Biological parents of children with CF will be invited to participate and included if their children meet the following criteria:
- children's age is more than 5 years and less than 20 years of age.
Who cannot join
- Biological parents of children younger than 5 years of age or older than 20 years of age.
- Step parents.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung infections in people with CF. Many young children do not have Pa in their lungs but will become infected as they get older. The investigators want to learn more about how Pa is passed from person to person, especially to someone with Cystic Fibrosis (CF).
Read the detailed description
People with CF (cystic fibrosis) often have lung infections which occur repeatedly or worsen over time. The lung infections are most often caused by bacteria. Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung infections in people with CF. Many young children do not have Pa in their lungs but will become infected as they get older. The investigators want to learn more about how Pa is passed from person to person, especially to someone with CF. The respiratory secretions of someone colonized with Pa can transmit or pass on the bacterium. The bacterium can be passed through direct contact by two individuals kissing or touching hands. Another way to pass Pa is by indirect contact such as touching an object like an eating utensil or drinking glass that has been used by someone with Pa.
There are many unanswered questions about Pa lung infections in people with CF. For example, it is not known why some people with CF develop Pa lung infections earlier than others. Nor is it known why it is difficult to eradicate Pa in some children and why some children's condition to deteriorate quicker than other after becoming infected with Pa.
Biological parents of children with CF are carriers of one CF causing gene mutation. It is also possible that they are carriers of additional, but milder, CF-related gene mutations. It is possible that the carrier status of the parents of CF children place them at risk of acquiring and carrying Pa in their lungs.
Biological parents of children who have CF will be asked to participate. This study plans to assess the frequency of Pa in biological parents and to correlate the clinical and microbiological status of CF children with PA carrier rates of their parents.
Parents will be asked to complete questionnaires at one routine, clinic visit, have nasal and throat cultures collected during their child's routine scheduled visit and again 3-4 months later (at another routine visit). The investigators are also asking permission to review the medical records of their child with CF.
- Conditions
- Pseudomonas Aeruginosa, Cystic Fibrosis
- Keywords
- Pseudomonas aeruginosa, cystic fibrosis
- Medical subject headings
- Pseudomonas Infections, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parents of PA positive CF children | parents of children with cystic fibrosis who are positive for Pseudomonas aeruginosa | |
| parents of Pa negative CF children | parents of children with cystic fibrosis who are negative for pseudomonas aeruginosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective: the incidence of Pseudomonas aeruginosa colonization in the upper respiratory tract of parents of children with CF.
Collection of nasal and oropharyngeal swabs will be obtained from parents living with patients at enrollment and after 3 months.
Measured: 6 months
Primary objective: the incidence of Pseudomonas aeruginosa colonization in the upper respiratory tract of parents of children with CF.
Collection of nasal and oropharyngeal swabs will be obtained from parents living with patients at enrollment and after 3 months.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pseudomonas AeruginosaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zafer Soultan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zafer Soultan, State University of New York - Upstate Medical University
- Investigators
- Zafer Soultan, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616862
- Sponsor's protocol ID
- 274342
- Status last verified
- May 2015
- First submitted
- 9 Jan 2012
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Microbiology and infectious disease in cystic fibrosis. Clinical Practice Guidelines for Cystic fibrosis; Cystic Fibrosis Foundation; Appendix V111, Volume V, Section I May 17-18, 1994
Kerem E, Rave-Harel N, Augarten A, Madgar I, Nissim-Rafinia M, Yahav Y, Goshen R, Bentur L, Rivlin J, Aviram M, Genem A, Chiba-Falek O, Kraemer MR, Simon A, Branski D, Kerem B. A cystic fibrosis transmembrane conductance regulator splice variant with partial penetrance associated with variable cystic fibrosis presentations. Am J Respir Crit Care Med. 1997 Jun;155(6):1914-20. doi: 10.1164/ajrccm.155.6.9196095.
PubMed 9196095Joel Moss form Pulmonary-Critical Care Medicine Branch, NHLBI, National Institutes of Health, Bethesda, Maryland, presented data stating that carriers of a CFTR gene mutations can be colonized by Pseudomonas aeruginoa. The data presented at The American Thoracic Society International Conference - 2005; in a seminar on Pseudomonas aeruginosa.
HUANG NN, SHEN KT. Staphylococcal carrier rates of patients with cystic fibrosis and of members of their families. J Pediatr. 1963 Jan;62:36-43. doi: 10.1016/s0022-3476(63)80068-2. No abstract available.
PubMed 13955349
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Carrier Rates of Pseudomonas Aeruginosa in Family Members of Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01616862
- Acronym / sponsor ID
- 274342
- Conditions
- Pseudomonas Aeruginosa, Cystic Fibrosis
- Keywords
- Pseudomonas aeruginosa, cystic fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Zafer SoultanUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 12 Jun 2012 (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.
Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung infections in people with CF. Many young children do not have Pa in their lungs but will become infected as they get older. The investigators want to learn more about how Pa is passed from person to person, especially to someone with Cystic Fibrosis (CF).
Detailed description
People with CF (cystic fibrosis) often have lung infections which occur repeatedly or worsen over time. The lung infections are most often caused by bacteria. Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung infections in people with CF. Many young children do not have Pa in their lungs but will become infected as they get older. The investigators want to learn more about how Pa is passed from person to person, especially to someone with CF. The respiratory secretions of someone colonized with Pa can transmit or pass on the bacterium. The bacterium can be passed through direct contact by two individuals kissing or touching hands. Another way to pass Pa is by indirect contact such as touching an object like an eating utensil or drinking glass that has been used by someone with Pa.
There are many unanswered questions about Pa lung infections in people with CF. For example, it is not known why some people with CF develop Pa lung infections earlier than others. Nor is it known why it is difficult to eradicate Pa in some children and why some children's condition to deteriorate quicker than other after becoming infected with Pa.
Biological parents of children with CF are carriers of one CF causing gene mutation. It is also possible that they are carriers of additional, but milder, CF-related gene mutations. It is possible that the carrier status of the parents of CF children place them at risk of acquiring and carrying Pa in their lungs.
Biological parents of children who have CF will be asked to participate. This study plans to assess the frequency of Pa in biological parents and to correlate the clinical and microbiological status of CF children with PA carrier rates of their parents.
Parents will be asked to complete questionnaires at one routine, clinic visit, have nasal and throat cultures collected during their child's routine scheduled visit and again 3-4 months later (at another routine visit). The investigators are also asking permission to review the medical records of their child with CF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents of PA positive CF children | – | –parents of children with cystic fibrosis who are positive for Pseudomonas aeruginosa |
| parents of Pa negative CF children | – | –parents of children with cystic fibrosis who are negative for pseudomonas aeruginosa |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Biological parents of children with cystic fibrosis who are treated at Upstate Medical University. Children's age is more than 5 yrs and less than 20 yrs.
Key inclusion criteria (2 listed)
- Biological parents of children with CF will be invited to participate and included if their children meet the following criteria:
Key exclusion criteria (2 listed)
- Biological parents of children younger than 5 years of age or older than 20 years of age.
- Step parents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary objective: the incidence of Pseudomonas aeruginosa colonization in the upper respiratory tract of parents of children with CF.
Time frame: 6 months
Collection of nasal and oropharyngeal swabs will be obtained from parents living with patients at enrollment and after 3 months.
Primary objective: the incidence of Pseudomonas aeruginosa colonization in the upper respiratory tract of parents of children with CF.
Time frame: Day 0
Collection of nasal and oropharyngeal swabs will be obtained from parents living with patients at enrollment and after 3 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 2 Jun 2015.
- BackgroundMicrobiology and infectious disease in cystic fibrosis. Clinical Practice Guidelines for Cystic fibrosis; Cystic Fibrosis Foundation; Appendix V111, Volume V, Section I May 17-18, 1994
- Background: PubMed 9196095Kerem E, Rave-Harel N, Augarten A, Madgar I, Nissim-Rafinia M, Yahav Y, Goshen R, Bentur L, Rivlin J, Aviram M, Genem A, Chiba-Falek O, Kraemer MR, Simon A, Branski D, Kerem B. A cystic fibrosis transmembrane conductance regulator splice variant with partial penetrance associated with variable cystic fibrosis presentations. Am J Respir Crit Care Med. 1997 Jun;155(6):1914-20. doi: 10.1164/ajrccm.155.6.9196095.
- BackgroundJoel Moss form Pulmonary-Critical Care Medicine Branch, NHLBI, National Institutes of Health, Bethesda, Maryland, presented data stating that carriers of a CFTR gene mutations can be colonized by Pseudomonas aeruginoa. The data presented at The American Thoracic Society International Conference - 2005; in a seminar on Pseudomonas aeruginosa.
- Background: PubMed 13955349HUANG NN, SHEN KT. Staphylococcal carrier rates of patients with cystic fibrosis and of members of their families. J Pediatr. 1963 Jan;62:36-43. doi: 10.1016/s0022-3476(63)80068-2. No abstract available.
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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.
Zafer Soultan, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudomonas Aeruginosa and Cystic Fibrosis, run by Zafer Soultan at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 2 Jun 2015. 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 States. 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?
Primary objective: the incidence of Pseudomonas aeruginosa colonization in the upper respiratory tract of parents of children with CF. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT01616862, which also lists 4 linked publications.
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 2 Jun 2015.