Ceftriaxone Dosage for Community-Acquired Pneumonia

(DC-CAP Trial)

Not yet recruiting at 3 trial locations
JD
Overseen ByJonathan D Baghdadi, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Maryland, Baltimore
Must be taking: Ceftriaxone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and safety of different Ceftriaxone doses for treating community-acquired pneumonia in hospitalized patients not in the ICU. Researchers aim to determine if a 1-gram daily dose works as well as a 2-gram daily dose but with fewer side effects. Suitable participants are those hospitalized with community-acquired pneumonia and currently receiving Ceftriaxone, without needing intensive care or advanced breathing support. As a Phase 4 trial, Ceftriaxone has already received FDA approval and proven effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Ceftriaxone?

Research has shown that both 1 gram and 2 grams of Ceftriaxone are usually well-tolerated by patients with community-acquired pneumonia. Studies have found no major difference in recovery between the two doses. For example, one study reported a 94.6% cure rate for patients taking 1 gram daily, similar to those taking 2 grams daily.

Regarding side effects, earlier research suggests that lower doses might cause fewer problems. A study comparing the two doses found that patients experienced fewer side effects with the 1 gram dose than with the 2 grams. This suggests the lower dose might be gentler on the body while still being effective.

Overall, both doses are considered safe, but the lower dose may have fewer side effects, making it a potentially safer choice for some patients.12345

Why are researchers enthusiastic about this study treatment?

Ceftriaxone is unique because it offers a potentially more streamlined approach to treating community-acquired pneumonia outside of the intensive care unit. Researchers are exploring different dosing levels—specifically, low-dose (1 gram daily) and moderate-dose (2 grams daily) regimens. Compared to other antibiotics like azithromycin or levofloxacin, ceftriaxone's administration through intravenous infusion allows for consistent delivery directly into the bloodstream, which could lead to faster and more effective results. By adjusting the dose, researchers hope to find the optimal balance that maximizes effectiveness while minimizing potential side effects. This tailored approach could make ceftriaxone a more adaptable and efficient option for treating this common lung infection.

What is the effectiveness track record for Ceftriaxone in treating community-acquired pneumonia?

Research has shown that ceftriaxone, an antibiotic, effectively treats pneumonia acquired outside hospitals. This trial will compare two dosages of ceftriaxone: a low dose of 1 gram daily and a moderate dose of 2 grams daily. Studies have found both dosages equally effective in curing the illness. For instance, one study found no significant difference in cure rates between patients taking 1 gram (94.6% cure rate) and those taking 2 grams. Another study showed that the likelihood of treatment failure was low and similar for both doses. Both doses are safe, but the lower dose might cause fewer side effects. Overall, ceftriaxone is a proven treatment for pneumonia, and both doses are effective.12346

Are You a Good Fit for This Trial?

This trial is for adults hospitalized with community-acquired pneumonia (lung infection caught outside the hospital), who are not in intensive care and have been prescribed Ceftriaxone within 72 hours of admission.

Inclusion Criteria

* Evaluated in the emergency department or within 72 hours of hospitalization
I have been prescribed Ceftriaxone for pneumonia I got outside the hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 1 gram or 2 grams of Ceftriaxone daily for community-acquired pneumonia

Up to 8 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

120 days

What Are the Treatments Tested in This Trial?

Interventions

  • Ceftriaxone

Trial Overview

The study compares two daily doses of the antibiotic Ceftriaxone—1 gram versus 2 grams—to see if the lower dose works just as well but causes fewer side effects. Patients are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Low Dose CeftriaxoneActive Control1 Intervention
Group II: Moderate Dose CeftriaxoneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+

Citations

Outcomes of ceftriaxone 2 g versus 1 g daily in hospitalized ...

Ceftriaxone is widely used for hospitalized patients with community-acquired pneumonia, but its optimal dosage remains unclear.

Efficacy-of-Ceftriaxone-1-g-daily-Versus-2- ...

Expert opinion: Ceftriaxone dosages of 1 g daily are as safe and effective as other antibiotic regimens for community-acquired pneumonia. Twenty ...

The case for using 1 gram of Ceftriaxone for community ...

They reported no statistically significant difference in clinical cure rates between patients receiving CTX 1 g IV every 24 hours (94.6%) and ...

Comparative prospective cohort study of efficacy and safety ...

This study aimed to compare initial treatment failure, 30-day mortality, and side effects between two groups of hospitalized adult CAP patients.

Comparative Efficacy of High- and Low-Dose Ceftriaxone ...

... 1 g was as effective as 2 g for community-acquired infections. Collectively, available PK data paired with clinical data indicates that in ...

Outcomes of ceftriaxone 2 g versus 1 g daily in hospitalized ...

Ceftriaxone is widely used for hospitalized patients with community-acquired pneumonia, but its optimal dosage remains unclear. Methods. We retrospectively ...