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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010122
Receipt No. R000011856
Scientific Title Clinical Efficacy of Cefditoren Pivoxil for Exacerbation of Chronic Obstructive Pulmonary Disease
Date of disclosure of the study information 2013/02/27
Last modified on 2019/09/05

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Basic information
Public title Clinical Efficacy of Cefditoren Pivoxil for Exacerbation of Chronic Obstructive Pulmonary Disease
Acronym Clinical Efficacy of CDTR-PI for COPD exacerbation
Scientific Title Clinical Efficacy of Cefditoren Pivoxil for Exacerbation of Chronic Obstructive Pulmonary Disease
Scientific Title:Acronym Clinical Efficacy of CDTR-PI for COPD exacerbation
Region
Japan

Condition
Condition Patients with COPD exacerbation and risk factors leading to severe, refractory infection
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of CDTR-PI (200 mg,3 times/day for 7 days) in patients with COPD exacerbation who can be treated on an outpatient basis or with oral antimicrobial agents under actual conditions of use
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes - 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)
Key secondary outcomes - 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Administration period: 7 days.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taiga Miyazaki
Organization Nagasaki University Hospital
Division name Second Department of Internal Medicine
Zip code
Address 1-7-1, Sakamoto, Nagasaki city, Nagasaki prefecture.
TEL 095-819-7273
Email taiga-m@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taiga Miyazaki
Organization Nagasaki evaluation organization for clinical interventions
Division name office
Zip code
Address 3-2-12, Uchikanda, Chiyodaku, Tokyo
TEL 03-5297-1052
Homepage URL
Email jimukyoku@neoci.or.jp

Sponsor
Institute Nagasaki evaluation organization for clinical interventions
Institute
Department

Funding Source
Organization Nagasaki evaluation organization for clinical interventions
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 長崎大学病院(長崎県)
日本赤十字社長崎原爆病院(長崎県)
長崎みなとメディカルセンター市民病院(長崎県)
日本赤十字社長崎原爆諫早病院(長崎県)
独立行政法人地域医療機能推進機構諫早総合病院(長崎県)
地方独立行政法人佐世保市総合医療センター(長崎県)
社会医療法人財団白十字会佐世保中央病院(長崎県)
医療法人伴帥会愛野記念病院(長崎県)
独立行政法人国立病院機構嬉野医療センター(佐賀県)
千住診療所(長崎県)
医療法人栄和会 泉川病院(長崎県)
まさき内科呼吸器クリニック(長崎県)
医療法人 英尚会 中村内科(長崎県)
医療法人 松本内科医院(長崎県)
医療法人 朝長医院(佐賀県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 27 Day

Related information
URL releasing protocol https://www.jiac-j.com/article/S1341-321X(19)30082-0/fulltext
Publication of results Published

Result
URL related to results and publications https://www.jiac-j.com/article/S1341-321X(19)30082-0/fulltext
Number of participants that the trial has enrolled 29
Results
Of the 23 patients finally analyzed, cure was achieved in 15 (65.2%), while 8 (34.8%) remained uncured at test of cure, which was set at 5-10 days after treatment ceased. The microbiological eradication rate was 88.9% at test of cure. During treatment, mild pneumonia was reported as an adverse event in one patient (3.4%). This study has provided positive evidence regarding the efficacy and safety of cefditoren pivoxil for the treatment of acute exacerbations of COPD.

 
Results date posted
2019 Year 09 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 29 patients enrolled in this study, 27 patients (93.1%) were male and most were elderly [mean (SD): 73.1 (8.1) years] with a high average smoking index [mean (SD): 1426.7 (931.7)].
Participant flow
This prospective, multicenter, single arm, interventional study was performed in 15 health care institutes from January 2013 to March 2017. We enrolled 29 patients with COPD exacerbations, of whom none met the exclusion criteria. However, six patients (20.7%) stopped their participation because of either adverse event (1 patient), concomitant disease (1 patient), or unknown reasons (4 patients).
Adverse events
During therapy, the only adverse event was pneumonia. This occurred in one patient, the severity was mild, and the condition resolved with appropriate therapy after 10 days. No serious adverse events were observed in any patient.
Outcome measures
The primary efficacy endpoint was the clinical cure rate at the test of cure. Secondary endpoints were the treatment effective rates on Day 4 and at the end of treatment, the bacteriological efficacy (bacteriological eradiation rates), and the safety outcomes.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 11 Month 30 Day
Date of IRB
2013 Year 01 Month 20 Day
Anticipated trial start date
2013 Year 01 Month 21 Day
Last follow-up date
2017 Year 04 Month 30 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 08 Month 31 Day
Date analysis concluded
2017 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 26 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011856

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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