Chronic Lung DiseasePhase 4NCT01326611
Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
A Phase 4 study testing Clarithromycin and Dextrose in people with Chronic Lung Disease, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of ureaplasma urealyticum and prevention of chronic lung disease in premature infants with birthweight < 1250 g and have ureaplasma urealyticum colonization. Read more about this study
- Who is it for?
- Ages 1 hour to 2 days
- Conditions the study is for
- Chronic Lung Disease
- What is being tested?
- Clarithromycin and Dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2008to Dec 2010
- 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 1 hour to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The babies under 1250 gram
- The babies must be appropriate for gestational age
Who cannot join
- Multiple congenital anomalies or known syndromes
- Intrauterine growth retardation with birthweight less than 10 percentile for gestational age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity Teaching Hospital Neonatology department
Ankara, 06600
About this study
The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of ureaplasma urealyticum and prevention of chronic lung disease in premature infants with birthweight < 1250 g and have ureaplasma urealyticum colonization.
- Conditions
- Chronic Lung Disease
- Being tested
- Clarithromycin, Dextrose
- Keywords
- Chronic lung disease, Clarithromycin, Ureaplasma urealyticum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
DextroseDrug
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycine Group: Active Comparator | Active comparator | Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days) Receives: Drug: Clarithromycin |
| Placebo Group: Placebo Comparator | Placebo comparator | Drug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days. Receives: Drug: Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges
Efficacy of clarithromycin in eradication of Ureaplasma and incidence of CLD were the major outcomes of the study. Nasopharyngeal swabs for Ureaplasma were taken in postnatal first 3 days and on the 12th day only in culture positive infants, transported to the laboratory and cultured for Uu immediately.
Measured: 12 days after treatment by clarithromycin
Secondary outcomes (1)
To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization.
Efficacy of clarithromycin in eradication of Ureaplasma urealyticum and incidence of chronic lung disease were the major outcomes of the study. Chronic lung disease of newborn was defined as a persistent oxygen requirement at 36 weeks post menstrual age or death.
Measured: From first day of inclusion of study to at postpartum 36th week of day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startMay 2008
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lung DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Omer Erdeve, Ass Prof, Study director, Zekai Tahir Burak Women's Health Research and Education HospitalEvrim Alyamac Dizdar, MD, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326611
- Sponsor's protocol ID
- rö05053781128
- Status last verified
- May 2008
- First submitted
- 29 Mar 2011
- Last updated
- 31 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants
- ClinicalTrials.gov ID
- NCT01326611
- Acronym / sponsor ID
- rö05053781128
- Conditions
- Chronic Lung Disease
- Keywords
- Chronic lung disease, Clarithromycin, Ureaplasma urealyticum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Mar 2011 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy of clarithromycin in eradication of ureaplasma urealyticum and prevention of chronic lung disease in premature infants with birthweight < 1250 g and have ureaplasma urealyticum colonization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clarithromycine Group: Active Comparator | Active comparator | Drug: ClarithromycinDrug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days) |
| Placebo Group: Placebo Comparator | Placebo comparator | Drug: DextroseDrug: D5W Dose given daily, IV same volume that Clarithromycin would be to equal 10 mg/kg for first 10 days. |
Who may qualify
- Ages
- 1 hour to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The babies under 1250 gram
- The babies must be appropriate for gestational age
Key exclusion criteria (2 listed)
- Multiple congenital anomalies or known syndromes
- Intrauterine growth retardation with birthweight less than 10 percentile for gestational age
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 |
|---|---|---|
| Clarithromycin | Drug | Clarithromycine Group: Active Comparator |
| Dextrose | Drug | Placebo Group: Placebo Comparator |
Primary outcome
To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges
Time frame: 12 days after treatment by clarithromycin
Efficacy of clarithromycin in eradication of Ureaplasma and incidence of CLD were the major outcomes of the study. Nasopharyngeal swabs for Ureaplasma were taken in postnatal first 3 days and on the 12th day only in culture positive infants, transported to the laboratory and cultured for Uu immediately.
1 secondary outcome
To evaluate the efficacy of clarithromycin in prevention of Chronic lung disease in premature infants with birthweight <1250 g and have Ureaplasma urealyticum colonization.
Time frame: From first day of inclusion of study to at postpartum 36th week of day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2011.
Related trials for Chronic Lung Disease
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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.
Omer Erdeve, Ass Prof study director
Zekai Tahir Burak Women's Health Research and Education Hospital
Evrim Alyamac Dizdar, MD principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clarithromycin and Dextrose in people with Chronic Lung Disease, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of clarithromycin in eradication of Ureaplasma urealyticum from premature nasopharynges (time frame: 12 days after treatment by clarithromycin). 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 31 Mar 2011.