Health TrialsbyHealthPanel

Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia

ConditionCommunity Acquired Pneumonia (CAP)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Evaluated in the emergency department or within 72 hours of hospitalization

Prescribed Ceftriaxone for community-acquired pneumonia

Disqualifiers

Planned or present admission to an intensive care unit

Respiratory failure requiring mechanical ventilation, non-invasive ventilation such as bilevel positive airway pressure, or high flow nasal cannula

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

430 Participants
are divided into 2 treatment groups
Group A: Low Dose CeftriaxoneActive comparator 1 intervention
Group B: Moderate Dose CeftriaxoneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical cure

Defined by discharge from the hospital or antibiotic treatment for \< 8 days without any of the following: requirement for antibiotic escalation, admission to an intensive care unit, mechanical or noninvasive ventilation, readmission within 30 days, or mortality within 30 days

Time frame
The outcome will be assessed 120 days after enrollment

Secondary outcomes

1

Time to stability

Time in days from randomization until stability defined by temperature \< 38, heart rate \< 100, respiratory rate \< 24, oxygen saturation \> 90%, systolic blood pressure ≥ 90, and return to baseline mental status based on Glasgow Coma Score

Time frame
The outcome will be assessed 90 days after enrollment
2

Days of antibiotic therapy

The aggregate sum of days for which any amount of a specific antimicrobial agent was administered during the hospital encounter

Time frame
The outcome will be assessed 90 days after enrollment
3

Antibiotic escalation

Defined by a change in antibiotic therapy that may include switching to an antibiotic with a broader spectrum up activity, adding an additional antibiotic, or increasing the dose of prescribed antibiotics within 5 days of randomization

Time frame
The outcome will be assessed 5 days after enrollment
4

ICU admission or requirement for mechanical ventilation

Admission to an intensive care unit or initiation of mechanical ventilation after randomization within the current hospitalization

Time frame
The outcome will be assessed 90 days after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: