Study protocol: Evaluation of efficacy and safety of Lascufloxacin in switch therapy for community-acquired pneumonia: a single arm, open-label clinical trial

JRCT ID: jRCTs071230001

Registered date:03/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Community-acquired pneumonia
• Date of first enrollment: 22/05/2023
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Lascufloxacin intravenous infusion is administered at a dose of 300 mg for the first infusion and 150 mg for the second and subsequent infusions once a day. The duration of the infusion is 60 minutes per 150 mg.
Treatment will be switched to lascufloxacin tablets after 3 to 5 days of lascufloxacin infusions if the patient meet the criteria for switch therapy.

Outcome(s)

• Primary Outcome: Cure rate at the time of test of cure (TOC) among switch therapy practitioners

Secondary Outcome

1.Percentage of patients treated with switch therapy
2.Results at early clinical evaluation, end of treatment (EOT), and TOC
3.Length of hospital stay
4.Factors for non-switch therapy

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who are 18 years and older at the time of informed consent.
(2) Patients who present acute manifestation of infiltrates in chest X-ray or high-resolution computed tomography image obtained within 48 hours from the initiation start of the study drug.
(3) Patients who meet both 1) and 2),
1)Patients who have at least one of the following symptoms,
a. Cough
b. Purulent sputum or sputum with increased purulence
c. Abnormal findings in auscultation or percussion (moist rales, dullness to percussion, decreased breath sounds, etc.)
d. Worsening of either or both dyspnea and tachypnea
e. Fever: >=37 Celsius degrees (axillary temperature)
2)Patients who have at least one of the following,
a. Increased CRP level
b. Increased white blood cell count (>10,000 per cubic millimeter), or stab cells >15%
c. Hypoxemia (PaO2<=60 Torr or SpO2<=90%)
(4) Patients who are classified mild or moderate severity by the A-DROP scoring system
(5) Patients who have written consent from the patient or his / her representative to participate in the study

Exclude criteria

(1) Patients with a previous history of hypersensitivity or serious adverse reaction to quinolones
(2) Patients with QT prolongation (QTc>=500ms)
(3) Patients with hypokalemia (K<=3.5mEq/L)
(4) Patients receiving Class IA (quinidine, procainamide, etc.) or Class III (amiodarone, sotalol, etc.) antiarrhythmic agents
(5) Patients with severe hepatic dysfunction (Child-Pugh class C)
(6) Women who are pregnant or may be pregnant
(7) Patients with the complications or history of convulsive disorder such as epilepsy etc.
(8) Patients with cardiac diseases such as arrhythmia like severe bradycardia, ischemic heart disease, or heart failure
(9) Patients with myasthenia gravis
(10) Patients with aortic aneurysm or aortic dissection, history of aortic aneurysm or aortic dissection, family history, or risk factors (Marfan syndrome, etc.)
(11) Patients with severe or progressive underlying disease or complication (diabetic patients with HbA1c>8.0% regardless of treatment, patients with advanced cancer whose prognosis cannot be expected during the observation period, patients with advanced cancer requiring surgery, etc.)
(12) White blood cell count <2,000 per cubic millimeter at the medical facility
(13) Active tuberculosis (including suspected cases), the following diseases for which pneumonia evaluation is not possible: primary lung cancer, malignancy with lung metastases, eosinophilic pneumonia, interstitial pneumonia, cystic fibrosis
(14) Respiratory infection patients caused by pathogens (acid-fast bacteria, fungi, viruses, etc.) that are unlikely to respond to study drugs
(15) Patients with bronchial obstruction or a history of obstructive pneumonia (patients with COPD are not excluded)
(16) Patients receiving systemic administration of other antimicrobial agents within 7 days prior to study drug administration (small-dose long-term macrolide and trimethoprim-sulfamethoxazole combination prophylaxis are not excluded)
(17) Patients with active hepatitis B or C virus infection, or HIV infection
(18) Patients with recurrent aspiration pneumonia
(19) Patients with performance status 3 or 4
(20) Patients who are participating in other interventional studies
(21) Patients who are judged unsuitable for participation of this trial by the principal or sub-investigator

Related Information

• Primary Sponsor: Mukae Hiroshi
• Secondary Sponsor: KYORIN Pharmaceutical Co.,Ltd.