ClinicalTrials.gg
Sign In
Status unknownNCT03400735Updated Jan 17, 2018

Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults

A Phase 4 interventional study of Cefdinir/clavulanic acide 300/125 mg film-coated tablets and Cefdinir 300Mg Capsule in Acute Exacerbation of Chronic Bronchitis and Community-Acquired Pneumoniae, sponsored by Neutec Ar-Ge San ve Tic A.Ş. Status unknown at 2 sites in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by Neutec Ar-Ge San ve Tic A.Ş · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Exacerbation of Chronic Bronchitis
  • Community-Acquired Pneumoniae

Browse trials for

03

In context

Bronchitis, Chronic

209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.

This study's planned enrollment of 50 is below the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.

Browse Bronchitis, Chronic studies →

Lead sponsor

Neutec Ar-Ge San ve Tic A.Ş is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The diagnosis of chronic bronchitis
  • The diagnosis of community-acquired pneumoniae
  • value = 30-80%
  • The diagnosis of mild-severe acute exacerbation of chronic bronchitis (AECB)
  • Oxygen saturation \< 90%

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Allergy against to penicillin or cephalosporins
  • Renal impairment
  • Active hepatic disease
  • Antibiotic use except study drugs
  • therapy before 6 months of study initiation
  • Use of probenecid like drugs
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Cefdinir/clavulanic acide 300/125 mg Film Coated Tablets

    Drug: Cefdinir 300Mg Capsule

  • Active comparator
    Cefdinir 300 mg Capsules

    Combination Product: Cefdinir/clavulanic acide 300/125 mg film-coated tablets

Interventions

  • Combination productCefdinir/clavulanic acide 300/125 mg film-coated tablets

    Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.

    Also known as: Fullcef Plus

  • DrugCefdinir 300Mg Capsule

    Cefdinir is used as comparator

06

What researchers measure

Primary outcomes

  1. The comparison of clinical success rates according to laboratory parameters

    Time frame: 7-10 days

Secondary outcomes

  1. The comparison of remission or relief of inflammation according to laboratory parameters

    Time frame: 7-10 days

  2. The comparison of patient satisfaction according to satisfaction questionnaire

    Time frame: 7-10 days

  3. The comparison of adverse events

    Time frame: 7-10 days

07

Study locations

2 of 2 sites recruiting
  • Erzincan University Mengücek Gazi Training and Research Hospital
    Erzincan, Turkey
    Recruiting
    • Edhem Ünver, Assoc Prof · Contact
    • Edhem Ünver, Assoc Prof · Principal investigator
  • Yedikule Chest Diseases Training and Research Hospital
    İstanbul, Turkey
    Recruiting
    • Sedat Altın, Prof Dr · Contact
    • Sedat Altın, Prof Dr · Principal investigator
    • Gülşah Günlüoğlu, Assoc Prof · Sub investigator
    • Nurdan Kalkan, MD · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2017 (actual). Primary completion is estimated for Apr 2018, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2016
First posted
Jan 17, 2018
StartActual
Nov 1, 2017
Primary completionEst.
Apr 1, 2018
CompletionEst.
Aug 1, 2018
Last update
Jan 17, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03400735
Lead sponsor
Neutec Ar-Ge San ve Tic A.Ş
Responsible party
Sponsor
First posted
Jan 17, 2018
Start date
Nov 1, 2017
Primary completion
Apr 1, 2018 (estimated)
Completion
Aug 1, 2018 (estimated)
Last update
Jan 17, 2018

Study contacts

Neutec R&D
Contact
iremkaraman@neutecrdc.com
00902128505102

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Cefdinir

Other studies in this condition

Bronchitis, Chronic →

Other studies from this sponsor

Neutec Ar-Ge San ve Tic A.Ş

Start the discussion