UreaplasmaPhase 1NCT00760279
An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates
A Phase 1 study testing Azithromycin in people with Ureaplasma and Bacterial Infection, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Ureaplasma, Bacterial Infection
- What is being tested?
- Azithromycin
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2005to not given
- Phase
- Phase 1
- 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 Up to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 24 to 37 weeks gestational age
- postnatal age 0 to 30 days
- May require therapy with antibiotics/anti-infectives
- 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
- Signed informed consent by the parent or guardian
Who cannot join
- Clinically significant hepatic disease (ALT or AST twice the normal value)
- Clinically significant anemia (hemoglobin < 10 gm %)
- Neutropenia (absolute neutrophil count < 500 cells/mm3)
- 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)]
- Cardiac rhythm abnormalities
- Critically ill patients
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106-6010
Wayne State
Detroit, Michigan, 48201
About this study
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
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.
Read the 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
- Ureaplasma, Bacterial Infection
- Being tested
- Azithromycin
- Keywords
- Bacterial infection, Azithromycin
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UreaplasmaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Pediatric Pharmacology Research Units Network, Children's Hospital of Michigan
- Investigators
- Elias Tessema, M.D., Principal investigator, Wayne StateDavid Edwards, Pharm.D., Principal investigator, Wayne StateJacob Aranda, M.D., Ph.D., Principal investigator, Wayne State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760279
- Sponsor's protocol ID
- PPRU10820
- Status last verified
- Sep 2008
- First submitted
- 25 Sep 2008
- Last updated
- 26 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00760279
- Acronym / sponsor ID
- PPRU10820
- Conditions
- Ureaplasma, Bacterial Infection
- Keywords
- Bacterial infection, Azithromycin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- Pediatric Pharmacology Research Units Network, Children's Hospital of Michigan
- Study start
- Sep 2005
- First posted
- 26 Sep 2008 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 24 to 37 weeks gestational age
- postnatal age 0 to 30 days
- May require therapy with antibiotics/anti-infectives
- 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
- Signed informed consent by the parent or guardian
Key exclusion criteria (7 listed)
- Clinically significant hepatic disease (ALT or AST twice the normal value)
- Clinically significant anemia (hemoglobin < 10 gm %)
- Neutropenia (absolute neutrophil count < 500 cells/mm3)
- 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)]
- Cardiac rhythm abnormalities
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 |
|---|---|---|
| Azithromycin | Drug | – |
Primary outcome
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.
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 26 Sep 2008.
Related trials for Ureaplasma
Enrolling by invitationObservational study
Vaginal Ecosystem and Network in the United States Study
Bacterial Vaginosis, Candidiasis
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.
Elias Tessema, M.D. principal investigator
Wayne State
David Edwards, Pharm.D. principal investigator
Wayne State
Jacob Aranda, M.D., Ph.D. principal investigator
Wayne State
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azithromycin in people with Ureaplasma and Bacterial Infection, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
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 5 inclusion and 7 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 26 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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.. 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 26 Sep 2008.