Study protocol: Evaluation of efficacy and safety of Lascufloxacin for Nursing and Healthcare Associated Pneumonia: single arm, open-label clinical trial

JRCT ID: jRCTs071200066

Registered date:16/12/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Nursing and healthcare-associated pneumonia
• Date of first enrollment: 30/03/2021
• Target sample size: 77
• Study type: Interventional
• Intervention(s): NHCAP patients are orally administered 75 mg of lascufloxacin once daily, for 7 days.

Outcome(s)

• Primary Outcome: Efficacy evaluation at the time of Test of Cure (TOC: 5 to 10 days after the end of treatment for pneumonia)

Secondary Outcome

1.Clinical efficacy at the time of End of Treatment (EOT)
2.Early clinical efficacy on 3 days after the first administration
3.Microbiological efficacy at the time of TOC (each of causative bacteria, each subject)
4.Microbiological efficacy at the time of EOT (each of causative bacteria, each subject)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients who are older than 20 at the time of informed consent.
2.Patients who present acute manifestation of obvious infiltrates in chest X-ray or high resolutionhigh-resolution computed tomography image obtained within 48 hours from the initiation start of 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, and decreased breath sounds, etc.)
d.Worsening of either or both of 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 by A-DROP scoring system
5.Patients who meet at least one of the following,
1)Admitting to a long-term-care or nursing home
2)Discharge from hospital in the preceding 90 days
3)Elder or physically disabled people who need care
4)Outpatients who regularly receive infusion therapy (including dialysis, antibiotics, anticancer agents, and immunosuppressant drugs, etc.) or hemodialysis
6.Patients who are able to take orally
7.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 the complications or past history of convulsive disorder such as epilepsy etc.
3.Female patients who are pregnant, or may be pregnant
4.Patients with severe dysfunction in liver or heart
5.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.)
6.White blood cell count <=2,000 per cubic millimeter at the medical facility
7.Severe infectious patients requiring treatment with intravenous antibacterial or mechanical ventilation
8.Patients with bronchial obstruction or a past history of obstructive pneumonia (but not excluding patients with COPD)
9.Patients with primary lung cancer or lung metastasis of malignant tumor that highly affect clinical evaluation of pneiumonia treatment
10.Pneumocystis pneumonia (including suspected cases), active pulmonary tuberculosis (including suspected cases).
Patients with eosinophilic pneumonia, interstitial pneumonia, cystic fibrosis that highly affect clinical evaluation of pneiumonia treatment
11.Patients who received systemic antibacterial within 7 days prior to administration of study drug (including long-term, low dose macrolide therapy)
12.Respiratory infections caused by pathogens (acid-fast bacilli, fungi, viruses, etc.) for which study drug is not expected to be effective
13.Patients with active hepatitis B or C virus infection, or HIV infection
14.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.