Preterm Premature Rupture of MembranePhase 4ADAPTNCT04294069
Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial
A Phase 4 study testing Azithromycin 500 mg and Azithromycin Oral Product in people with Preterm Premature Rupture of Membrane, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Read more about this study
- Who is it for?
- Ages 14 to 65 years, women only
- Conditions the study is for
- Preterm Premature Rupture of Membrane
- What is being tested?
- Azithromycin 500 mg and Azithromycin Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2020to 1 Apr 2021
- 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 14 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Singleton gestation 24 0/7 -33 0/7 weeks'
- Diagnosed with preterm premature rupture of membranes:
- History consistent with ruptured membranes (ie leaking, gush of fluid)
- Sterile speculum exam with pooling
- Fluid positive for ferning and/or nitrazine
- With or without confirmatory test such as Amnisure
Who cannot join
- • Contraindication to azithromycin
- Active labor, abruption, chorioamnionitis at enrollment
- Other contraindication to expectant management of PPROM at enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Azithromycin Pharmacokinetics and Pharmacodynamics in Pregnancy and Preterm Birth Prevention: Optimizing Dosing to Improve Maternal and Neonatal Outcomes
This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care.
Read the detailed description
This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care. During the course of eight days participants will have serial collection of amniotic fluid, maternal serum; and at delivery, of placenta, membrane, and cord blood. After delivery, neonatal respiratory samples will be collected as well.
- Conditions
- Preterm Premature Rupture of Membrane
- Being tested
- Azithromycin 500 mg, Azithromycin Oral Product
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin 500 mgDrug
500mg azithromycin PO for seven days starting on admission
Azithromycin Oral ProductDrug
1000mg azithromycin PO once at admission
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin 500mg | Active comparator | 500mg azithromycin PO daily for seven days Receives: Drug: Azithromycin 500 mg |
| Azithromycin 1000mg | Active comparator | 1000mg azithromycin PO once at admission Receives: Drug: Azithromycin Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Azithromycin trough in amniotic fluid
Primary outcome is the mean difference in azithromycin trough (Cmin) in amniotic fluid between the two dosing regimens using nonparametric test
Measured: 8 days
Secondary outcomes (8)
IL-6 in amniotic fluid
Mean difference in IL-6 at delivery or 8 days (which ever is first)
Measured: 8 days
IL-8 in cord blood
Mean difference in IL-8 in cord blood
Measured: 3 months (delivery)
Respiratory ureaplasma colonization in neonate
Culture of nasopharyngeal swab within 48 hours of delivery in neonates
Measured: 3 months
Latency to delivery
Number days from admission to delivey
Measured: 3 months
Intra-amniotic infection
Incidence of maternal intra-amniotic infection at delivery
Measured: 3 months (delivery)
Trend in amniotic fluid cytokines
TNF alpha, IL-1B, IL-6, IL-8 over 8 day period from admission
Measured: 8 days
ureaplasma colonization of membranes
Culture swab taken of membranes after delivery
Measured: 3 months
Histologic chorioamnionitis
incidence of histologic chorioamnionitis in placental pathology
Measured: 3 months (delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start14 Sep 2020
- Primary completion27 Dec 2020
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm Premature Rupture of MembraneStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Christiana Care Health Services
- Responsible party
- Sponsor
- Investigators
- Rupsa C Boelig, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294069
- Sponsor's protocol ID
- 20G.119
- Acronym
- ADAPT
- Status last verified
- Jul 2023
- First submitted
- 18 Feb 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD available on request pending completion of data sharing agreement and approval of information requested
Publications
Boelig RC, Lam K, Rochani A, Soni V, Kaushal G, Kraft WK. Azithromycin dosing and preterm premature rupture of membranes treatment (ADAPT): a randomized controlled Phase I trial. Am J Obstet Gynecol MFM. 2024 Sep;6(9):101423. doi: 10.1016/j.ajogmf.2024.101423. Epub 2024 Jul 6.
PubMed 38977063
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin Pharmacokinetics and Pharmacodynamics in Pregnancy and Preterm Birth Prevention: Optimizing Dosing to Improve Maternal and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT04294069
- Acronym / sponsor ID
- ADAPT / 20G.119
- Conditions
- Preterm Premature Rupture of Membrane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Christiana Care Health Services
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 27 Dec 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 3 Mar 2020 (actual)
- 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.
This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care.
Detailed description
This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care. During the course of eight days participants will have serial collection of amniotic fluid, maternal serum; and at delivery, of placenta, membrane, and cord blood. After delivery, neonatal respiratory samples will be collected as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Azithromycin 500mg | Active comparator | Drug: Azithromycin 500 mg500mg azithromycin PO daily for seven days |
| Azithromycin 1000mg | Active comparator | Drug: Azithromycin Oral Product1000mg azithromycin PO once at admission |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Singleton gestation 24 0/7 -33 0/7 weeks'
- Diagnosed with preterm premature rupture of membranes:
Key exclusion criteria (3 listed)
- • Contraindication to azithromycin
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 500 mg500mg azithromycin PO for seven days starting on admission | Drug | Azithromycin 500mg |
| Azithromycin Oral Product1000mg azithromycin PO once at admission | Drug | Azithromycin 1000mg |
Primary outcome
Azithromycin trough in amniotic fluid
Time frame: 8 days
Primary outcome is the mean difference in azithromycin trough (Cmin) in amniotic fluid between the two dosing regimens using nonparametric test
8 secondary outcomes
IL-6 in amniotic fluid
Time frame: 8 days
IL-8 in cord blood
Time frame: 3 months (delivery)
Respiratory ureaplasma colonization in neonate
Time frame: 3 months
Latency to delivery
Time frame: 3 months
Intra-amniotic infection
Time frame: 3 months (delivery)
Trend in amniotic fluid cytokines
Time frame: 8 days
ureaplasma colonization of membranes
Time frame: 3 months
Histologic chorioamnionitis
Time frame: 3 months (delivery)
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 27 Jul 2023.
- Derived from this study: PubMed 38977063Boelig RC, Lam K, Rochani A, Soni V, Kaushal G, Kraft WK. Azithromycin dosing and preterm premature rupture of membranes treatment (ADAPT): a randomized controlled Phase I trial. Am J Obstet Gynecol MFM. 2024 Sep;6(9):101423. doi: 10.1016/j.ajogmf.2024.101423. Epub 2024 Jul 6.
- Individual participant dataSharing planned: Yes. IPD available on request pending completion of data sharing agreement and approval of information requested
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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.
Rupsa C Boelig, MD principal investigator
Thomas Jefferson University
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 Azithromycin 500 mg and Azithromycin Oral Product in people with Preterm Premature Rupture of Membrane, run by Thomas Jefferson University at 1 site 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 6 inclusion and 3 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 27 Jul 2023. 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 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 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?
Azithromycin trough in amniotic fluid (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04294069, which also lists 1 linked publication.
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 27 Jul 2023.