Acute Exacerbation of Chronic BronchitisPhase 4NCT03400735
Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults
A Phase 4 study testing Cefdinir/clavulanic acide 300/125 mg film-coated tablets and Cefdinir 300Mg Capsule in people with Acute Exacerbation of Chronic Bronchitis and Community-Acquired Pneumoniae, run by Neutec Ar-Ge San ve Tic A.Ş at 2 sites in Turkey (Türkiye).
Trial summary
It is planned to compare the efficacy and safety of cefdinir and cefdinir/clavulanic acide treatments in acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumoniae (CAP) patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Exacerbation of Chronic Bronchitis, Community-Acquired Pneumoniae
- What is being tested?
- Cefdinir/clavulanic acide 300/125 mg film-coated tablets and Cefdinir 300Mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of chronic bronchitis
- The diagnosis of community-acquired pneumoniae
- FEV1 value = 30-80%
- The diagnosis of mild-severe acute exacerbation of chronic bronchitis (AECB)
- Oxygen saturation < 90%
Who cannot join
- Pregnancy or breastfeeding
- Allergy against to penicillin or cephalosporins
- Renal impairment
- Active hepatic disease
- Antibiotic use except study drugs
- Immunosuppressive therapy before 6 months of study initiation
- Use of probenecid like drugs
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Erzincan University Mengücek Gazi Training and Research Hospital
Erzincan
Edhem Ünver, Assoc Prof
Edhem Ünver, Assoc Prof
- Recruiting
Yedikule Chest Diseases Training and Research Hospital
Istanbul
Sedat Altın, Prof Dr
Sedat Altın, Prof Dr
About this study
Official title: Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Treatment of Acute Exacerbation of Chronic Bronchitis (AECB) and Community-acquired Pneumonia (CAP) in Adults
It is planned to compare the efficacy and safety of cefdinir and cefdinir/clavulanic acide treatments in acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumoniae (CAP) patients.
- Being tested
- Cefdinir/clavulanic acide 300/125 mg film-coated tablets, Cefdinir 300Mg Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefdinir/clavulanic acide 300/125 mg film-coated tabletsCombination product
Also called Fullcef Plus
Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.
Cefdinir 300Mg CapsuleDrug
Cefdinir is used as comparator
| Study group | Role | What they receive |
|---|---|---|
| Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets | Experimental | Not described Receives: Drug: Cefdinir 300Mg Capsule |
| Cefdinir 300 mg Capsules | Active comparator | Not described Receives: Combination Product: Cefdinir/clavulanic acide 300/125 mg film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of clinical success rates according to laboratory parameters
Measured: 7-10 days
Secondary outcomes (3)
The comparison of remission or relief of inflammation according to laboratory parameters
Measured: 7-10 days
The comparison of patient satisfaction according to satisfaction questionnaire
Measured: 7-10 days
The comparison of adverse events
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Nov 2017
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400735
- Sponsor's protocol ID
- NEU-08.16
- Status last verified
- Jan 2018
- First submitted
- 3 Oct 2016
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Treatment of Acute Exacerbation of Chronic Bronchitis (AECB) and Community-acquired Pneumonia (CAP) in Adults
- ClinicalTrials.gov ID
- NCT03400735
- Acronym / sponsor ID
- NEU-08.16
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is planned to compare the efficacy and safety of cefdinir and cefdinir/clavulanic acide treatments in acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumoniae (CAP) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets | Experimental | Drug: Cefdinir 300Mg Capsule |
| Cefdinir 300 mg Capsules | Active comparator | Combination Product: Cefdinir/clavulanic acide 300/125 mg film-coated tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The diagnosis of chronic bronchitis
- The diagnosis of community-acquired pneumoniae
- FEV1 value = 30-80%
- The diagnosis of mild-severe acute exacerbation of chronic bronchitis (AECB)
- Oxygen saturation < 90%
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding
- Allergy against to penicillin or cephalosporins
- Renal impairment
- Active hepatic disease
- Antibiotic use except study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefdinir/clavulanic acide 300/125 mg film-coated tabletsAlso: Fullcef PlusCefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone. | Combination product | Cefdinir 300 mg Capsules |
| Cefdinir 300Mg CapsuleCefdinir is used as comparator | Drug | Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets |
Primary outcome
The comparison of clinical success rates according to laboratory parameters
Time frame: 7-10 days
3 secondary outcomes
The comparison of remission or relief of inflammation according to laboratory parameters
Time frame: 7-10 days
The comparison of patient satisfaction according to satisfaction questionnaire
Time frame: 7-10 days
The comparison of adverse events
Time frame: 7-10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Exacerbation of Chronic Bronchitis
Enrolling by invitationObservational study
The Italian Registry of Patients With Chronic Obstructive Pulmonary Disease
COPD, COPD Exacerbation Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefdinir/clavulanic acide 300/125 mg film-coated tablets and Cefdinir 300Mg Capsule in people with Acute Exacerbation of Chronic Bronchitis and Community-Acquired Pneumoniae, run by Neutec Ar-Ge San ve Tic A.Ş at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neutec R&D (00902128505102, iremkaraman@neutecrdc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The comparison of clinical success rates according to laboratory parameters (time frame: 7-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.