Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants

NCT01326611 | Completed Phase 4 DMC

• 1 other identifier: rö05053781128
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Lung Disease

Keywords

Chronic lung disease; Clarithromycin; Ureaplasma urealyticum

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  From first day of inclusion of study to at postpartum 36th week of day

Study Arms (2)

Clarithromycine Group: Active Comparator

ACTIVE COMPARATOR

Drug: Clarithromycin intravenous clarithromycin (10 mg/kg twice a day for 10 days)

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.

Drug: Dextrose

Interventions

Clarithromycin DRUG

Clarithromycine Group: Active Comparator

Dextrose DRUG

Placebo Group: Placebo Comparator

Eligibility Criteria

• Age: 1 Hour - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The babies under 1250 gram
• The babies must be appropriate for gestational age

You may not qualify if:

• Multiple congenital anomalies or known syndromes
• Intrauterine growth retardation with birthweight less than 10 percentile for gestational age

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

Study Sites (1)

Zekai Tahir Burak Maternity Teaching Hospital Neonatology department

Ankara, 06600, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Clarithromycin; Glucose

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Omer Erdeve, Ass Prof

  Zekai Tahir Burak Women's Health Research and Education Hospital

  STUDY DIRECTOR

• Evrim Alyamac Dizdar, MD

  Zekai Tahir Burak Women's Health Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 31, 2011
• Study Start: May 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 31, 2011

Record last verified: 2008-05

Locations

TU (1)