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

900 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

Antibiotic escalation within 5 days of randomization

Defined by increasing the dose or frequency of Ceftriaxone, starting additional antibiotics not ordered concurrently with Ceftriaxone, or changing Ceftriaxone to an antibiotic with a broader spectrum up activity

Time frame
The outcome will be assessed 5 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, return to baseline mental status based on Glasgow Coma Score, and PO diet or medication ordered

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

Clinical deterioration within 10 days of randomization

Defined by admission to an intensive care unit, mechanical ventilation, or in-hospital mortality on any hospital day, or supplemental oxygen \>2 L after hospital day 3

Time frame
The outcome will be assessed 10 days after enrollment
3

Ceftriaxone-associated toxicity within 10 days of randomization

Defined by new development of Hemoglobin \< 10, elevated liver enzymes or or total bilirubin, clinically significant diarrhea (represented by Clostridioides difficile testing), or rash (represented by consult to dermatology)

Time frame
The outcome will be assessed 10 days after enrollment
4

Ranked composite outcome

Rank 1 (highest rank) = no antibiotic escalation, clinical deterioration, or Ceftriaxone-associated toxicity Rank 2 = antibiotic escalation without clinical deterioration or Ceftriaxone-associated toxicity Rank 3 = Ceftriaxone-associated toxicity without clinical deterioration Rank 4 = clinical deterioration without 30-day mortality Rank 5 = 30-day mortality

Time frame
The outcome will be assessed 30 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: