Clinical Trials Logo
  1. Home
  2. Bacterial Infection
  3. NCT00760279

An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates

Bacterial Infection Clinical Trial

Official title:
An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates Pediatric Pharmacology Research Unit, Children's Hospital of Michigan

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of IV azithromycin in preterm neonates and confirm that the pharmacokinetics of azithromycin is similar in the 24-<32 week and 32-<37 week neonate. The dose of 10 mg/kg has been chosen on the basis of previous pediatric pharmacokinetic studies.

Clinical Trial Description

In vitro studies with azithromycin show good inhibitory activity against U. urealyticum. Pharmacokinetic studies of azithromycin in older children show better tolerance, higher tissue concentration, fewer side effects, and fewer drug interactions, when compared to erythromycin. Thus far, there have been no published data on the pharmacokinetic profile of azithromycin in neonates including low birth weight infants. However, the clinical pharmacology profile suggests a substantial therapeutic advantage of this drug in the newborn. To date, there are no data on the PK profile of IV Azithromycin from whence rational dosing can be derived. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00760279
Study type Interventional
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact
Status Completed
Phase Phase 1
Start date September 2005
View Details
See also
  Status Clinical Trial Phase
Completed NCT02794831 - Exposure to NSAIDs (Non Steroidal Anti-Inflammatory Drugs) and Severity of Community-acquired Bacterial Infections
Active, not recruiting NCT02533609 - Elimination of Antibiotics During Citrate-anticoagulated Continuous-veno-venous-haemodialysis
Completed NCT01892358 - Preventing Bacterial and Viral Infections Among Injection Drug Users N/A
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Completed NCT01446289 - Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings Phase 2
Completed NCT01059890 - Cerebral Antibiotics Distribution After Acute Brain Injury Phase 1
Completed NCT00389558 - Antiseptic Use and Dressing Application Phase 4
Completed NCT02311816 - Increase in Procalcitonin Kinetics May be a Good Indicator of Starting Empirical Antibiotic Treatment in Critically Ill Patients N/A
Completed NCT01225042 - The Effect of Probiotics on E. Coli Gastroenteritis N/A
Completed NCT00800488 - Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months N/A
Not yet recruiting NCT00765778 - Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community N/A
Completed NCT00915213 - Incidence of Antibiotic Resistant E.Coli in Patients Undergoing Repeat Prostate Biopsy N/A
Terminated NCT00307099 - Comparative Antibiotic Therapy for Subjects With Pulmonary Infiltrates in the ICU Phase 3
Recruiting NCT04479657 - Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection Early Phase 1
Completed NCT03299894 - Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department N/A
Completed NCT01817075 - Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant Phase 3
Completed NCT01244698 - Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction Phase 4
Completed NCT01250574 - Neutrophil CD64 and Procalcitonin as Novel Biomarkers for Postoperative Infections
Completed NCT01012089 - Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease N/A
Withdrawn NCT00430469 - Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients Phase 1/Phase 2