## Protocol Section
### Identification Module
**NCT ID:** NCT00760279

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

**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

#### Organization Study ID Info
**ID:** PPRU10820
#### Organization
**Class:** NIH
**Full Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2008-09-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-09-25

**Overall Status:** COMPLETED

#### Start Date
**Date:** 2005-09

**Status Verified Date:** 2008-09

#### Study First Post Date
**Date:** 2008-09-26
**Type:** ESTIMATED
**Study First Submit Date:** 2008-09-25
**Study First Submit QC Date:** 2008-09-25
### Sponsor Collaborators Module

#### Collaborators

**Class:** NETWORK

**Name:** Pediatric Pharmacology Research Units Network

**Class:** OTHER

**Name:** Children's Hospital of Michigan

#### Lead Sponsor

**Class:** NIH

**Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Ureaplasma

- Bacterial Infection

**Keywords:**

- Bacterial infection

- Azithromycin

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 16

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Azithromycin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Safety: Patients will be monitored for clinical adverse events and have standard hematology labs drawn within 72 hours of study entry. Liver function tests, renal function tests and standard chemistries will be drawn prior to and at the end of the study.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. 24 to 37 weeks gestational age
2. postnatal age 0 to 30 days
3. May require therapy with antibiotics/anti-infectives
4. Have baseline Hematology labs available (hemoglobin, hematocrit, white blood cell and differential and platelet count), which have been obtained within the previous 72 hours, as part of their standard of care
5. Signed informed consent by the parent or guardian

Exclusion Criteria:

1. Clinically significant hepatic disease (ALT or AST twice the normal value)
2. Clinically significant anemia (hemoglobin \< 10 gm %)
3. Neutropenia (absolute neutrophil count \< 500 cells/mm3)
4. Clinically significant renal disease \[Creatinine clearance twice the normal value, as calculated by the Schwartz formula : Length in cms x k (a constant) / S.Cr (Values for the constant are given in Appendix 1)\]
5. Cardiac rhythm abnormalities
6. Critically ill patients
7. Patients who are on or expected to be on the following concurrent medications carbamazepine, phenytoin, theophylline, digoxin, warfarin, ergot alkaloids, triazolam, cyclosporine, terfenadine, hexobarbital and antacids.

**Maximum Age:** 30 Days

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Detroit

**Country:** United States

**Facility:** Wayne State

**State:** Michigan

**Zip:** 48201

**Location 2:**

**City:** Cleveland

**Country:** United States

**Facility:** Rainbow Babies and Children's Hospital

**State:** Ohio

**Zip:** 44106-6010

#### Overall Officials

**Official 1:**

**Affiliation:** Wayne State

**Name:** Elias Tessema, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Wayne State

**Name:** David Edwards, Pharm.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Wayne State

**Name:** Jacob Aranda, M.D., Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007239

- Term: Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: HIGH

- As Found: Bacterial Infections

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001424

- Term: Bacterial Infections

### Intervention Browse Module - Ancestors

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M20132

- Name: Azithromycin

- Relevance: HIGH

- As Found: 20 minutes

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017963

- Term: Azithromycin

### Misc Info Module

- Version Holder: 2024-05-24
