Comparative Efficacy of Levofloxacin versus Ceftriaxone and Azithromycin for Treating Community Acquired Pneumonia

To compare the treatment outcomes of levofloxacin alone with combination therapy of azithromycin and ceftriaxone for treating CAP in hospitalized patients having a CURB-65 score of ≤ 02 with mild to moderate CAP.

Single-center, two-arm, parallel-group, open-label randomized controlled trial. A total of 150 participants will be randomly allocated in a 1:1 ratio to receive either levofloxacin or ceftriaxone plus azithromycin.

The trial will be conducted at the Pulmonology Department, Sheikh Zayed Medical College, Rahim Yar Khan, Pakistan. Eligible hospitalized adults will be screened and enrolled after written informed consent. Participants will be randomly allocated 1:1 to levofloxacin or ceftriaxone plus azithromycin and monitored during hospitalization for treatment response, adverse events and study outcomes. The trial is open-label.

Adults aged 18–70 years, of either sex, with mild-to-moderate community-acquired pneumonia and a Confusion, Urea, Respiratory rate, Blood pressure and age 65 years or older (CURB-65) score of 2 or less will be included. Patients with major drug allergy to study antibiotics, pregnancy or breastfeeding, HIV/AIDS, or more than 24 hours of prior antibiotic treatment for the current illness will be excluded.

Levofloxacin group: levofloxacin 750 mg intravenously once daily for 5 days. Combination group: ceftriaxone 1 g intravenously twice daily plus azithromycin 500 mg intravenously once daily for 5 days.

Oxygen saturation (SpO₂), Length of hospital stay, Body temperature, Cough frequency and severity.

Eligible participants who provide informed consent will be randomly allocated individually in a 1:1 ratio to either the levofloxacin group or the ceftriaxone plus azithromycin group. Simple randomization will be performed using a computer-generated random allocation sequence. The sequence will be generated before participant recruitment by an independent investigator who is not involved in recruitment or treatment. Sequentially numbered, opaque, sealed envelopes will be used for allocation concealment. After enrollment and baseline assessment, the next envelope in sequence will be opened to reveal the treatment assignment.

Deidentified individual participant data will not be shared because participant consent does not include unrestricted data sharing. To protect participant confidentiality and comply with institutional ethics requirements, there is no current plan to make the IPD publicly available.

Study Protocol and Informed Consent Form. These documents will be made available in PDF format after publication of the primary study results upon reasonable request to the corresponding investigator. All confidential information will be removed before sharing

The documents will be available after publication of the primary study results and will remain available for five years thereafter upon reasonable request.

Qualified researchers, clinicians, and academic investigators with a scientifically sound research proposal and appropriate institutional or ethics approval, if applicable.

Documents will be shared upon reasonable request for legitimate scientific research purposes. Requests will be reviewed by the principal investigator. Recipients must agree to use the documents only for the approved research purpose and maintain confidentiality.

Requests should be sent by email to the corresponding investigator. The study protocol and informed consent form will be provided electronically (PDF format) after approval of the request by the principal investigator.

Researchers should submit a written request describing the research objectives and intended use of the documents. The principal investigator will review the request for scientific merit and ethical appropriateness. If approved, the requested documents will be shared electronically within 2–4 weeks.