NCT00273676

Brief Summary

Patients with severe community-acquired pneumonia are included Half of the patients are treated with a 3 day course of intravenous antibiotics, followed, when clinical stable, by a course of oral antibiotics. Efficacy of this treatment is compared to a standard course of 7 days of intravenous antibiotics, which treatment is assigned to the other half of patients. Outcomes measured are clinical cure and costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2000

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
Last Updated

January 9, 2006

Status Verified

January 1, 2006

First QC Date

January 5, 2006

Last Update Submit

January 5, 2006

Conditions

Severe Communtity-Acquired Pneumonia

Keywords

Community-acquired pneumoniaTreatmentAntibiotics

Outcome Measures

Primary Outcomes (1)

  • Clinical cure at day 28 of the study

Secondary Outcomes (2)

  • Costs for treatment both inside and outside the hospital

  • Quality of life

Interventions

Conversion to oral antibiotic treatment after 3 days of intravenous antibiotic treatmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients with cystic fibrosis, a history of colonization with Gram negative bacteria due to structural damage to the respiratory tract, malfunction of the digestive tract, life expectancy of less than 1 month due to underlying diseases, infections other than pneumonia needing antibiotic treatment, severe immunosuppression (neutropenia (\<0,5 x 109 / l) or a CD4 count \< 200 / mm3) and needing mechanical ventilation in an intensive care unit were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

Utrecht, Utrecht, 3508 GA, Netherlands

Location

Related Publications (1)

  • Oosterheert JJ, Bonten MJ, Schneider MM, Buskens E, Lammers JW, Hustinx WM, Kramer MH, Prins JM, Slee PH, Kaasjager K, Hoepelman AI. Effectiveness of early switch from intravenous to oral antibiotics in severe community acquired pneumonia: multicentre randomised trial. BMJ. 2006 Dec 9;333(7580):1193. doi: 10.1136/bmj.38993.560984.BE. Epub 2006 Nov 7.

    PMID: 17090560DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Andy IM Hoepelman, Professor of Medicine

    University Medical Center, Department of Internal Medicine and Infectious Diseases, Utrecht, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 9, 2006

Study Start

July 1, 2000

Study Completion

March 1, 2004

Last Updated

January 9, 2006

Record last verified: 2006-01

Locations

NL(1)