Streptoccus Pseudopneumoniae atAssiut UniversityHospitals | NCT03528759

Studies
Streptoccus Pseudopneumoniae atAssiut UniversityHospitals

NCT03528759

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Feb 5, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pneumonia
Streptococcus Infection

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Estimated

Primary Completion Date

Aug 1, 2019Estimated

Completion Date

Aug 3, 2019Estimated

First Submitted Date

Mar 26, 2018

First Submission Date that Met QC Criteria

May 17, 2018

First Posted Date

May 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2019

Last Update Posted Date

Feb 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
	Diagnostic Test	phenotypic and genotypic Method		Bile solubility test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
identification of Streptococcus. pseudopneumoniae	Streptococcus will be identified by polymerase chain Reaction under complete aseptic condition	1year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients showing signs of respiratory tract infection

Exclusion Criteria:

No exclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26461259	Result	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.
23231485

ID	Term
D011014	Pneumonia
D013290	Streptococcal Infections

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases