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Extended Azithromycin Treatment in Prelabor Rupture of Membranes

21 czerwca 2026 zaktualizowane przez: Alexa Henderson

Extended Azithromycin Treatment in Peri-viable and Extremely Preterm Prelabor Rupture of Membranes: A Pilot Study

The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age.

Researchers will compare the standard antibiotic treatment to the standard antibiotic treatment with additional doses of azithromycin.

Participants will:

  • Be randomly assigned to one of two groups:
  • The standard antibiotic treatment
  • The standard antibiotic treatment plus 7 additional doses of oral azithromycin 500 mg every other day.
  • Participants will be asked to complete a survey regarding their experience and side effects.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Multiple randomized trials have shown that antibiotic treatment for preterm prelabor rupture of membranes (PPROM) increases pregnancy latency and decreases maternal and neonatal morbidity. However, the optimal dosing schedule for azithromycin in PPROM is not fully understood. This pilot study will assess the feasibility of a non-blinded, randomized-controlled trial comparing maternal and neonatal outcomes between the standard PPROM antibiotic regimen and the standard regimen with extended azithromycin therapy in participants with periviable and extremely preterm PPROM between 22- and 28-weeks gestational age. Preliminary data on pregnancy latency, maternal morbidity, and neonatal outcomes will also be collected. Findings from this feasibility study will inform the design of a future, powered study.

The investigators hypothesize that extended azithromycin therapy may be associated with longer pregnancy latency and decreased rates of maternal and neonatal morbidity compared to standard therapy. This hypothesis is exploratory, and the present feasibility study is not powered to test a hypothesis.

The primary objective is to evaluate the feasibility of conducting a non-blinded, randomized controlled trial of extended azithromycin therapy in participants with periviable and extremely preterm prelabor rupture of membranes (PPROM) who desire expectant management between 22 and 28 weeks gestational age. Specifically, we aim to assess feasibility metrics including recruitment and consent rates, randomization procedures, adherence to the study protocol, and completeness of follow-up.

The secondary objectives of this pilot study are to estimate the variability (standard deviation) of pregnancy latency in this population to inform sample-size calculations for a future definitive trial. The investigators will also collect preliminary data on maternal outcomes (e.g., rates of intra-amniotic infection, endometritis, and placental abruption) and neonatal outcomes (gestational age at delivery, NICU admission, morbidity) for planning purposes. Additionally, the investigators will review placental pathology reports to identify the stage/grade of chorioamnionitis per the Amsterdam criteria. The investigators will obtain an initial estimate of the effect of extended azithromycin on pregnancy latency, recognizing that this pilot study is not powered to detect clinically meaningful differences.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15217
        • University of Pittsburgh Magee-Womens Hospital
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Christina Megli, MD, PhD
        • Pod-śledczy:
          • Alexa Henderson, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Singleton gestation
  • Gestational age at time of PPROM between 22w0d and 28w0d
  • Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care)
  • Remain pregnant 48 hours after presentation.
  • Patients who receive betamethasone, magnesium therapy, and/or a limited course of tocolysis (through the betamethasone window) will be included.
  • Pregnant patients below the age of 18 are eligible.

Exclusion Criteria:

  • Contraindications to expectant management (clinical intra-amniotic infection, active preterm labor, or acute placental abruption)
  • Lethal congenital defects
  • Multiple gestation
  • Ongoing alternative antibiotic treatment
  • Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic
  • History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
  • Known prolongation of QT interval
  • History of torsades de pointes
  • Congenital long QT syndrome
  • Bradyarrhythmia
  • Decompensated heart failure
  • Drugs known to significantly prolong the QT interval including Class 1A and Class III antiarrhythmic agents
  • Impaired hepatic function
  • GFR<10 mL/min
  • Diagnosis of myasthenia gravis

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Standard Antibiotic Regimen
A single dose of oral azithromycin 1 gram which is given at the time of presentation in addition to the standard intravenous ampicillin 2g q6h for 48 hours followed by oral amoxicillin 250 mg q8 hours for 5 days.
Lek: Standard Azithromycin Dosing
Oral Azithromycin 1g once.
Eksperymentalny: Extended Azithromycin Regimen
The standard antibiotic regimen will be given in addition to Azithromycin 500g every other day for 7 additional doses.
Lek: Standard Azithromycin Dosing
Oral Azithromycin 1g once.
Lek: Azithromycin (Azithro)
Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Recruitment Capability
Ramy czasowe: From recruitment to enrollment, up to 3 days.
Number of participants recruited per week/month
From recruitment to enrollment, up to 3 days.
Participant Eligibility
Ramy czasowe: From recruitment until enrollment, up to 3 days.
Percentage of eligible participants who agree to participate, reasons for refusal or ineligibility
From recruitment until enrollment, up to 3 days.
Retention and Dropout Rates
Ramy czasowe: From recruitment to completion of the study, up to 4 months.
Percentage of patients who complete study and reasons for withdrawal from study.
From recruitment to completion of the study, up to 4 months.
Intervention Delivery
Ramy czasowe: From recruitment to completion of intervention, up to 15 days.
Percentage of interventions delivered as intended
From recruitment to completion of intervention, up to 15 days.
Participant Acceptability
Ramy czasowe: At completion of study (either after Day 14 of study or after delivery if does not complete study) prior to hospital discharge.
Likert-scale survey evaluating the participant's perceived affective attitude, burden, ethicality, intervention coherence, confidence, opportunity costs, general acceptability, and side effects related to the study.
At completion of study (either after Day 14 of study or after delivery if does not complete study) prior to hospital discharge.
Data Collection Procedures
Ramy czasowe: From recruitment to completion of postpartum period, up to 6 months.
Data completeness measured as number of participants with complete data entry.
From recruitment to completion of postpartum period, up to 6 months.
Resource Use and Cost
Ramy czasowe: From recruitment to postpartum period, up to 6 months.
Total cost versus planned budget, time and staffing required.
From recruitment to postpartum period, up to 6 months.
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Ramy czasowe: Ongoing during treatment from Day 2 through Day 14. Formally assessed with surveys as above on Day 8 and Day 14 (or earlier if delivers prior to completion of study period).
Adverse events associated with antibiotic usage, maternal and neonatal outcomes, bacterial resistance profiles. Assessed using previously validated Medication Side Effect survey.
Ongoing during treatment from Day 2 through Day 14. Formally assessed with surveys as above on Day 8 and Day 14 (or earlier if delivers prior to completion of study period).
Protocol Deviations
Ramy czasowe: From recruitment to completion of intervention, up to 15 days.
Incidence of protocol deviation, indications for protocol deviation.
From recruitment to completion of intervention, up to 15 days.
Time for Delivery
Ramy czasowe: From recruitment to completion of postpartum period, up to 6 months.
Amount of study team time needed for delivery.
From recruitment to completion of postpartum period, up to 6 months.
Financial Resources
Ramy czasowe: From recruitment to postpartum period, up to 6 months.
Amount of monetary resources needed for study delivery.
From recruitment to postpartum period, up to 6 months.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Pregnancy Latency
Ramy czasowe: From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
Number of days participants remain pregnant after PPROM until delivery
From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
Pregnancy Outcome
Ramy czasowe: From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
Intrauterine fetal demise, neonatal demise while in NICU, living infant to NICU discharge.
From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.
NICU Admission
Ramy czasowe: From day of delivery through neonatal discharge, up to 4 months.
Requirement for NICU admission.
From day of delivery through neonatal discharge, up to 4 months.
Neonatal Ventilatory Support
Ramy czasowe: From day of delivery through neonatal discharge, up to 4 months.
Level of ventilatory support required for neonate (none, bubble CPAP, intubation).
From day of delivery through neonatal discharge, up to 4 months.
Neonatal Sepsis
Ramy czasowe: From day of delivery through neonatal discharge, up to 4 months.
Rates of early-onset sepsis, late-onset sepsis (including culture positive sepsis and culture-negative, clinically suspected sepsis)
From day of delivery through neonatal discharge, up to 4 months.
Neonatal Intraventricular Hemorrhage (IVH)
Ramy czasowe: From day of delivery through neonatal discharge, up to 4 months.
Grade of IVH if present.
From day of delivery through neonatal discharge, up to 4 months.
Neonatal respiratory distress syndrome
Ramy czasowe: From day of delivery through neonatal discharge, up to 4 months.
Documented respiratory distress syndrome by neonatology providers.
From day of delivery through neonatal discharge, up to 4 months.
Necrotizing enterocolitis
Ramy czasowe: From day of delivery through neonatal discharge, up to 4 months.
Rate of documented necrotizing enterocolitis by neonatology team.
From day of delivery through neonatal discharge, up to 4 months.
Mode of delivery
Ramy czasowe: From day of PPROM (D0) through day of delivery, up to 3 months.
Cesarean section, vaginal delivery, or operative delivery.
From day of PPROM (D0) through day of delivery, up to 3 months.
Indication for delivery
Ramy czasowe: From day of PPROM (D0) through day of delivery, up to 3 months.
Non-reassuring fetal status, labor, intra-uterine infection, placental abruption, cord prolapse.
From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal group B streptococcus status
Ramy czasowe: From day of PPROM (D0) through day of delivery, up to 3 months.
Positive or negative group B streptococcus maternal rectovaginal culture.
From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal postpartum hemorrhage
Ramy czasowe: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Estimated blood loss greater than 1000mL after delivery.
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Suspected intraamniotic infection
Ramy czasowe: From day of PPROM (D0) through day of delivery, up to 3 months.
Defined as maternal temperature greater than 39 degrees Celsius OR maternal temperature between 38.0-38.9 degrees Celsius plus one or more additional clinical risk factors: maternal leukocytosis greater than 15,000/mm^3, purulent cervical drainage, or fetal tachycardia.
From day of PPROM (D0) through day of delivery, up to 3 months.
Confirmed intraamniotic infection
Ramy czasowe: From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
Positive amniotic fluid test result OR placental pathology demonstrating histologic evidence of infection or inflammation.
From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
Maternal sepsis
Ramy czasowe: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Suspected sepsis documented by clinical provider in chart or culture proven sepsis.
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal placental abruption
Ramy czasowe: From day of PPROM (D0) through day of delivery, up to 3 months.
Clinical evidence of placental abruption documented by OBGYN provider.
From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal ICU Admission
Ramy czasowe: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Required admission to adult ICU prior to or after delivery.
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal postpartum endomtritis
Ramy czasowe: From day of delivery through 6 weeks postpartum.
Documented clinical diagnosis of endometritis in participant chart.
From day of delivery through 6 weeks postpartum.
Maternal retained products of conception
Ramy czasowe: From day of delivery through 6 weeks postpartum.
Clinical documentation of retained products of conception in participant chart.
From day of delivery through 6 weeks postpartum.
Additional maternal surgical procedures
Ramy czasowe: From day of delivery through 6 weeks postpartum.
Requirement of additional surgical procedures following delivery (suction dilation and curettage, hysterectomy).
From day of delivery through 6 weeks postpartum.
Maternal blood transfusion
Ramy czasowe: From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Documented maternal blood transfusion following delivery.
From day of PPROM (D0) through 6 weeks postpartum, up to 4 months.
Maternal antibiotic course completion
Ramy czasowe: From day of PPROM (D0) through day of delivery, up to D14.
Number of participants in intervention arm who completed the extended antibiotic course.
From day of PPROM (D0) through day of delivery, up to D14.
Additional maternal antibiotic administration
Ramy czasowe: From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal antibiotics administered for other indications after enrollment in the study.
From day of PPROM (D0) through day of delivery, up to 3 months.
Maternal placental pathology
Ramy czasowe: From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.
Maternal and fetal inflammation stage/grade as defined by the Amsterdam Criteria.
From day of PPROM (D0) through delivery with postpartum placental pathology result, up to 3 months.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Alexa Henderson

Śledczy

  • Główny śledczy: Christina Megli, MD/PhD, University of Pittsburgh Magee-Womens Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 maja 2028

Ukończenie studiów (Szacowany)

1 lipca 2028

Daty rejestracji na studia

Pierwszy przesłany

29 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

25 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

25 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY25110085

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

All IPD collected throughout the study will potentially be shared with future collaborating sites if the feasibility trial is expanded to a multi-center trial.

Ramy czasowe udostępniania IPD

Beginning 3 months after publication without end.

Kryteria dostępu do udostępniania IPD

Collaborating principal investigators will have access to IPD. The information will be shared upon request via secure email or to advance further research efforts in the case of a multi-site trial.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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