Efficacy and safety of lascufloxacin in GAS antigen positive adult pharyngotonsillitis

JRCT ID: jRCTs051240134

Registered date:25/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pharyngotonsillitis caused by group A streptococci
• Date of first enrollment: 12/11/2024
• Target sample size: 48
• Study type: Interventional

Intervention(s)

-The study drug is orally administered once a day, one tablet at a time, at the same time of day.
-The administered period is 5 to 7 days in principle.
-The maximum administration period is 14 days and it is determined by the principal or sub-investigator based on the results of medical judgment.

Outcome(s)

• Primary Outcome: Clinical efficacy rate at the end of treatment (EOT)

Secondary Outcome

(1) Microbiological effect to GAS
(2) Subjective symptoms and other findings
1)Sub-scores of primary endpoints (clinical efficacy rate at EOT)
2)Clinical evaluation using symptom score and pharyngeal tonsil score
3)Scores of each parameter in the symptom diary
(3) Body temperature
(4) Frequency of antipyretic analgesic use

Key inclusion & exclusion criteria

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

Include criteria

(1) More than eighteen years old patients at informed consent.
(2) Patients detected group A streptococcus antigen by rapid antigen test.
(3) Acute pharyngotonsillitis patients regarded mild or moderate severity (Total score >= 2).
(4) Patients given written consent to participate in the study.

Exclude criteria

(1) Patients with a previous history of hypersensitivity or serious adverse reaction to quinolones.
(2) Women who are pregnant or possibly pregnant, and breastfeeding women.
(3) Patients with respiratory infection caused by pathogens that are unlikely to respond to study drugs (SARS-CoV-2, influenza virus, etc.).
(4) Patients receiving systemic administration of other antimicrobial agents within 7 days prior to study drug administration.
(5) Patients judged to be preferentially treated with surgical or intravenous antimicrobial agents by the principal or co-investigator.
(6) Patients with or suspected habitual or recurrent tonsillitis.
(7) Patients with infectious mononucleosis caused by Epstein-Barr virus.
(8) Patients with comorbidities or the history of concomitant illness such as sore throat or fever that affect the evaluation of acute pharyngitis/tonsillitis, and patients judged inappropriate for participation of this study by the principal or co-investigator.
(9) Patients needed or scheduled to receive concomitant medications that are prohibited during the study period.
(10) Patients with severe or progressive comorbidities or receiving immunosuppressive therapy.
(11) Patients with active tuberculosis, hepatitis B or C virus infection, or HIV infection.
(12) Patients with immunodeficiency diseases.
(13) Patients judged inappropriate for participation of this study by the investigator or sub-investigator.

Related Information

• Primary Sponsor: Hotomi Muneki
• Secondary Sponsor: KYORIN Pharmaceutical Co., Ltd.