Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07537413
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Community Acquired Pneumonia (CAP)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ceftriaxone 1 gram daily — DRUG
    Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of non-critical community-acquired pneumonia.
  • Ceftriaxone 2 grams daily — DRUG
    Intravenous Ceftriaxone will be dosed at 2 grams daily per institutional guidance for treatment of community-acquired pneumonia.

Study Details

Aim: Demonstrate the equivalent efficacy and superior safety of Ceftriaxone 1 gram daily compared with Ceftriaxone 2 grams daily among hospitalized patients with community-acquired pneumonia who are not admitted to the intensive care unit.\<p\> Hypothesis: Among hospitalized patients outside of the intensive care unit with community-acquired pneumonia who are prescribed Ceftriaxone, a dosage of 1 gram daily will be associated with an equivalent rate of clinical cure and fewer adverse events than a dosage of 2 grams daily.

Key Dates

First listed
Apr 17, 2026
Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Low Dose Ceftriaxone
    Intravenous Ceftriaxone will be dosed 1 gram daily per institutional guidance for treatment of community-acquired pneumonia outside of the intensive care unit.
  • Active Comparator: Moderate Dose Ceftriaxone
    Intravenous Ceftriaxone will be dosed 2 grams daily per institutional guidance for treatment of community-acquired pneumonia outside of the intensive care unit.

Primary Outcome Measure

Antibiotic escalation within 5 days of randomization [ Time Frame: The outcome will be assessed 5 days after enrollment ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21201
Megan Dunning, MD
[email protected]
410-328-8667
University of Maryland Medical Center - Midtown CampusBaltimoreMaryland21201
Jonathan Baghdadi, MD, PhD
[email protected]
410-225-8000
UM Baltimore Washington Medical CenterGlen BurnieMaryland21061
Stephanie Pires, PharmD
[email protected]
410-787-4000
University of Maryland St. Joseph Medical CenterTowsonMaryland21204
Rose Kohinke, PharmD
[email protected]
410-337-1000

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University of Maryland Medical Center· Baltimore, MDUniversity of Maryland Medical Center - Midtown Campus· Baltimore, MDUM Baltimore Washington Medical Center· Glen Burnie, MDUniversity of Maryland St. Joseph Medical Center· Towson, MD

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