NCT00901602

Brief Summary

Streptococcus pneumoniae (pneumococcus) is a bacterium that causes severe infections in children and adults such as meningitis, pneumonia, and blood stream infection. There are many types of these bacteria defined by the type of sugar coat that they have. These are classified as serotypes. There are common serotypes that cause severe disease and are preventable by vaccination of children. Other less common types are more difficult to prevent. The investigators aim to determine the serotypes that cause invasive pneumococcal disease in Lebanon and to study their sensitivity to different antibiotics. The investigators will collect bacterial isolates from different hospitals in Lebanon isolated from the blood or spinal fluid of patients with invasive pneumococcal disease. This information will help the investigators determine the usefulness of available pneumococcal vaccines in preventing these infections. The data will be distributed to all primary care physicians treating children in Lebanon and will be shared with the Ministry of Health.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
53mo left

Started Oct 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Oct 2005Oct 2030

Study Start

First participant enrolled

October 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
21.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

25 years

First QC Date

May 8, 2009

Last Update Submit

February 2, 2023

Conditions

Keywords

streptococcus pneumoniaepneumococcuspneumoniameningitisserotypesbacteremiasepsis

Outcome Measures

Primary Outcomes (1)

  • Serotype prevalence of S. pneumoniae in invasive pneumococcal disease

    yearly

Secondary Outcomes (1)

  • Determine the antibiotic sensitivity of S. pneumoniae and the association with specific serotypes

    yearly

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with invasive pneumococcal disease with positive culture of S. pneumoniae from a normally sterile site (blood, CSF, etc.)

You may qualify if:

  • Samples included in the study are those that are:
  • culture proven
  • invasive pneumococcal infections
  • in patients of all ages admitted to different hospitals all over Lebanon
  • Acceptable samples include:
  • positive isolates from blood
  • cerebrospinal fluid
  • other normally sterile body sites such as empyema fluid, abscesses, joint fluid, middle ear fluid obtained by tympanocentesis in the operating room, and lung needle aspiration

You may not qualify if:

  • non S. pneumoniae isolates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, 113-6044, Lebanon

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial isolates

MeSH Terms

Conditions

PneumoniaMeningitisSepsisBacteremia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesNeuroinflammatory DiseasesNervous System DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Ghassan S Dbaibo, M.D.

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghassan S Dbaibo, M.D.

CONTACT

Mireille Lteif, RN

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 14, 2009

Study Start

October 1, 2005

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Last Updated

February 3, 2023

Record last verified: 2023-02

Locations