PneumoniaNCT03528759
Streptoccus Pseudopneumoniae atAssiut UniversityHospitals
An observational study of Pneumonia and Streptococcus Infection, run by Assiut University.
Trial summary
Streptococcus pseudopneumoniae as suggested by DNA-DNA homology studies is recorded as a species of the Streptococcus mitis/oralis members of viridans group Streptococci; they have some similar features to the Streptococcus mitis/oralis members of viridans Streptococcus pneumoniae Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumonia, Streptococcus Infection
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to 3 Aug 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sputum samples will be collected from all studied patients under complete aseptic condition. sputum specimens will be cultivated on 5% sheep blood agar, chocolate agar (Oxoid, UK.
Who may be able to join
- All patients showing signs of respiratory tract infection
Who cannot join
- No exclusion criteria
About this study
Official title: Streptococcus Pseudopneumoniae as an Emerging Respiratory Tract Pathogen at Assiut University Hospitals
Streptococcus pseudopneumoniae as suggested by DNA-DNA homology studies is recorded as a species of the Streptococcus mitis/oralis members of viridans group Streptococci; they have some similar features to the Streptococcus mitis/oralis members of viridans Streptococcus pneumoniae
Read the detailed description
principle characteristics of Streptococcus. pseudopneumoniae are the lacking of pneumococcal capsule, bile insolubility, the indeterminate sensitivity Or resistance to optochin after incubation in Carbon dioxide (5%), while sensitivity to it after incubation in ambient air Streptococcus . pseudopneumoniae was firstly described in sputum samples of patients with lower respiratory tract infection, particularly those with Chronic Obstructive PulmonaryDiseases pseudopneumoniae is usually misidentified in our laboratories as we usually rely on optochin sensitivity testing with 5% Carbon dioxide detection of Streptococcus. pneumoniae and miss the incubation in ambient air which is the key point for identification of Streptococcus. pseudopneumoniae. Biochemical reactions are usually used to differentiate typical pneumoniae from Streptococc Streptococcus . pseudopneumoniae and other related Streptococci; several molecular techniques have also been used There are several polymerase chain reaction based assays that target specific pneumococcal virulence factors for the typical Streptococc Streptococcus . pneumoniae, such as autolysin A which is the major pneumococcal autolysin and the capsular polysaccharide biosynthesis gene A which is a conservedpneumococcal capsular polysaccharide gene , also aliB-like ORF2 (a gene that usually found in the capsular region of non-capsulated pneumococci; these genetic markers have been used to differentiate S. pneumoniae from other related species.
- Conditions
- Pneumonia, Streptococcus Infection
- Medical subject headings
- Pneumonia, Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test
Also called Bile solubility test
phenotypic and genotypic Method
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of Streptococcus. pseudopneumoniae
Streptococcus will be identified by polymerase chain Reaction under complete aseptic condition
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Jul 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion3 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Abdelfadeel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528759
- Sponsor's protocol ID
- ZIS
- Status last verified
- May 2018
- First submitted
- 26 Mar 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raddaoui A, Simoes AS, Baaboura R, Felix S, Achour W, Ben Othman T, Bejaoui M, Sa-Leao R, Ben Hassen A. Serotype Distribution, Antibiotic Resistance and Clonality of Streptococcus pneumoniae Isolated from Immunocompromised Patients in Tunisia. PLoS One. 2015 Oct 13;10(10):e0140390. doi: 10.1371/journal.pone.0140390. eCollection 2015.
PubMed 26461259Charalambous BM. Identifying divergent streptococcal strains using pherotype: implications for pathogen emergence and epidemiology. Future Microbiol. 2012 Dec;7(12):1349-54. doi: 10.2217/fmb.12.114.
PubMed 23231485Leung MH, Ling CL, Ciesielczuk H, Lockwood J, Thurston S, Charalambous BM, Gillespie SH. Streptococcus pseudopneumoniae identification by pherotype: a method to assist understanding of a potentially emerging or overlooked pathogen. J Clin Microbiol. 2012 May;50(5):1684-90. doi: 10.1128/JCM.00131-12. Epub 2012 Feb 29.
PubMed 22378913
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streptococcus Pseudopneumoniae as an Emerging Respiratory Tract Pathogen at Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT03528759
- Acronym / sponsor ID
- ZIS
- Conditions
- Pneumonia, Streptococcus Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 3 Aug 2019 (estimated)
- First posted
- 18 May 2018 (actual)
- 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.
Streptococcus pseudopneumoniae as suggested by DNA-DNA homology studies is recorded as a species of the Streptococcus mitis/oralis members of viridans group Streptococci; they have some similar features to the Streptococcus mitis/oralis members of viridans Streptococcus pneumoniae
Detailed description
principle characteristics of Streptococcus. pseudopneumoniae are the lacking of pneumococcal capsule, bile insolubility, the indeterminate sensitivity Or resistance to optochin after incubation in Carbon dioxide (5%), while sensitivity to it after incubation in ambient air Streptococcus . pseudopneumoniae was firstly described in sputum samples of patients with lower respiratory tract infection, particularly those with Chronic Obstructive PulmonaryDiseases pseudopneumoniae is usually misidentified in our laboratories as we usually rely on optochin sensitivity testing with 5% Carbon dioxide detection of Streptococcus. pneumoniae and miss the incubation in ambient air which is the key point for identification of Streptococcus. pseudopneumoniae. Biochemical reactions are usually used to differentiate typical pneumoniae from Streptococc Streptococcus . pseudopneumoniae and other related Streptococci; several molecular techniques have also been used There are several polymerase chain reaction based assays that target specific pneumococcal virulence factors for the typical Streptococc Streptococcus . pneumoniae, such as autolysin A which is the major pneumococcal autolysin and the capsular polysaccharide biosynthesis gene A which is a conservedpneumococcal capsular polysaccharide gene , also aliB-like ORF2 (a gene that usually found in the capsular region of non-capsulated pneumococci; these genetic markers have been used to differentiate S. pneumoniae from other related species.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sputum samples will be collected from all studied patients under complete aseptic condition. sputum specimens will be cultivated on 5% sheep blood agar, chocolate agar (Oxoid, UK.
Key inclusion criteria (1 listed)
- All patients showing signs of respiratory tract infection
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Also: Bile solubility testphenotypic and genotypic Method | Diagnostic test | – |
Primary outcome
identification of Streptococcus. pseudopneumoniae
Time frame: 1year
Streptococcus will be identified by polymerase chain Reaction under complete aseptic condition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Results publication: PubMed 26461259Raddaoui A, Simoes AS, Baaboura R, Felix S, Achour W, Ben Othman T, Bejaoui M, Sa-Leao R, Ben Hassen A. Serotype Distribution, Antibiotic Resistance and Clonality of Streptococcus pneumoniae Isolated from Immunocompromised Patients in Tunisia. PLoS One. 2015 Oct 13;10(10):e0140390. doi: 10.1371/journal.pone.0140390. eCollection 2015.
- Results publication: PubMed 23231485Charalambous BM. Identifying divergent streptococcal strains using pherotype: implications for pathogen emergence and epidemiology. Future Microbiol. 2012 Dec;7(12):1349-54. doi: 10.2217/fmb.12.114.
- Results publication: PubMed 22378913Leung MH, Ling CL, Ciesielczuk H, Lockwood J, Thurston S, Charalambous BM, Gillespie SH. Streptococcus pseudopneumoniae identification by pherotype: a method to assist understanding of a potentially emerging or overlooked pathogen. J Clin Microbiol. 2012 May;50(5):1684-90. doi: 10.1128/JCM.00131-12. Epub 2012 Feb 29.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Streptococcus Infection, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
identification of Streptococcus. pseudopneumoniae (time frame: 1year). 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 NCT03528759, which also lists 3 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 5 Feb 2019.