Patients with COPD exacerbation and risk factors leading to severe, refractory infection
Conditions
Interventions
Administered drug: Cefditoren pivoxil (trade name: Meiact MS Tablets 100 mg). Administration method: 200 mg (potency) (2 tablets), orally administered postprandially, three times per day. Administra
Sponsors
Nagasaki evaluation organization for clinical interventions
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Location for treatment: Outpatient or in-hospital. 2)Diagnostic criterion for COPD: A pulmonary function test was conducted in the past 12 months and the latest stable forced expiratory volume in 1 second (FEV1.0/FVC) is under 70%. 3)Risk factors associated with severe, refractory infection. At least one of the following factors is present. (1) age: 65 years or older. (2) COPD treatment history of at least 1 year. (3) At least 2 exacerbations of infection in the past year. (4) Reduced pulmonary function when free of infection. Criteria for reduced pulmonary function are as follows: - Oxygen therapy necessary - Pulmonary function test showing %FEV1.0 of under 80% - PaO2 or under 65 Torr (SpO2 or under 92%) - etc. (5) History of respiratory management using a mechanical ventilator. (6) Cardiovascular disease, diabetes, renal disorder or various malignant diseases that require treatment as underlying disorders. (7) Connective tissue disease, etc., that might impact infections. 4)Diagnostic criteria for exacerbation of COPD (1)Mandatory condition: Both (a) and (b) must be met. (a)New onset of coughing/sputum or increase in the amount of sputum or worsening of purulence. (b)CRP elevation (or over 0.7 mg/dL, or exceeding the institution's upper limit) or increase in peripheral WBCs (or over 8,000/mm3, or exceeding the institution's upper limit). (2)Selected criteria: It is desirable that the following conditions be met: (a)Availability of high-quality samples (P sputum) that are likely to enable identification of the causative organism(s). (b)Fever: or over 37 degree Centigrade (axillary measurement). (c)General malaise or worsening of respiratory distress. (d)Presence of pneumococcus in sputum confirmed with a pneumococcus kit.
Exclusion criteria
Exclusion criteria: 1)History of allergy, possibly due to cephem derivatives. 2)Advanced renal dysfunction (eGFR under 30 mL/min/1.73 m2). 3)Presence of pneumonia that cannot be expected to improve by oral administrations of antibiotics. 4)Confirmed influenza virus infection. However, acute exacerbation of COPD due to secondary bacterial infections after influenza can be enrolled. 5)Presence of cystic fibrosis, active pulmonary tuberculosis or nontuberculous mycobacterial infection (including suspected). 6)Antimicrobial agents were administered within 1 week, or concomitant administration of other antimicrobial agents was necessary. However, this will not apply to patients who have been continued on low-dose, long-term macrolide therapy since before entry, as long as the dosage remains unchanged. 7)Undergoing a chronic immunosuppressive treatment using immunosuppressants. 8)A need for additional administration of oral or injectable steroids. Inhaled steroids are permitted up to 10 mg of prednisolone equivalents per day, but there should be no need for a dosage increase. 9)Complications such as a serious pulmonary malignant tumor, congestive heart failure, bronchiectasis or pneumothorax that may confound interpretation of the efficacy of the study drug. 10)Inability to administer oral antimicrobial agents (dietary nutrition is impossible). 11)Patients who are or may be pregnant, breast-feeding women and women who desire to become pregnant during the study drug administration period. 12)Any other reason that the chief investigator judges as rendering a patient inappropriate for enrollment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - Clinical efficacy at completion of administration (efficacy rate) - Clinical efficacy 3 days after administration (early evaluation of drug efficacy) - Bacterial disappearance rate 5-10 days after completing administration | — |
Primary
| Measure | Time frame |
|---|---|
| - Clinical efficacy at 5-10 days after completing administration (judgment of cure) - Adverse events during the evaluation period (If causality cannot be denied: adverse drug reaction) | — |
Countries
Japan
Contacts
Public ContactTaiga Miyazaki
Nagasaki evaluation organization for clinical interventions office
Outcome results
None listed