NCT00358202

Brief Summary

Randomized trial of nursing home residents with pneumonia to assess if intramuscular cefepime is a safe, efficacious, and cost-effective alternative to once daily intramuscular ceftriaxone for the treatment of elderly nursing home residents who develop pneumonia and do not require hospitalization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2002

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

March 1, 2002

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2006

Completed
Last Updated

October 31, 2007

Status Verified

October 1, 2007

First QC Date

July 27, 2006

Last Update Submit

October 29, 2007

Conditions

Pneumonia

Keywords

intramuscular antibioticsnursing home acquired pneumonianhappharmacoeconomicscefepimeceftriaxone

Outcome Measures

Primary Outcomes (1)

  • Total cost of all antibiotics.

    7-14 days

Secondary Outcomes (1)

  • Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs.

    7-14 days

Study Arms (2)

1 cefepime

ACTIVE COMPARATOR
Drug: cefepime

2 ceftriaxone

ACTIVE COMPARATOR
Drug: ceftriaxone

Interventions

cefepimeDRUG

cefepime hydrochloride 1gm IM q24h

1 cefepime
ceftriaxoneDRUG

ceftriaxone 1 gm IM q24h

2 ceftriaxone

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPL Associates,LLC

Buffalo, New York, 14226, United States

Location

MeSH Terms

Conditions

Pneumonia

Interventions

CefepimeCeftriaxone

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCefotaximeCephacetrile

Study Officials

  • Joseph A Paladino, PharmD

    CPL Associates, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2006

First Posted

July 31, 2006

Study Start

March 1, 2002

Study Completion

April 1, 2006

Last Updated

October 31, 2007

Record last verified: 2007-10

Locations

US(1)