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| ID | Type | Description | Link |
|---|---|---|---|
| UM1AI068632 | U.S. NIH Grant/Contract | View source | |
| UM1AI068616 | U.S. NIH Grant/Contract | View source | |
| UM1AI106716 | U.S. NIH Grant/Contract | View source | |
| HHSN275201800001I | Other Identifier | Eunice Kennedy Shriver National Institute of Child Health and Human Development |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute of Mental Health (NIMH) |
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IMPAACT 2044 is a study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy. Up to 78 pregnant women receiving (1) ceftriaxone for indications other than syphilis or (2) benzathine penicillin G for treatment of syphilis from non-study clinical care providers will be enrolled at study sites located in the United States. Approximately 22 infants of pregnant participants receiving benzathine penicillin G will also be enrolled.
IMPAACT 2044 is a Phase IV, multi-site, open-label, non-randomized, opportunistic study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy.
The study includes two arms, with Arm 1 subdivided by route of administration:
Arm 1A: Intravenous (IV) ceftriaxone Arm 1B: Intramuscular (IM) ceftriaxone Arm 2: IM benzathine penicillin G
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active comparator: Arm 1A: IV ceftriaxone | Intravenous ceftriaxone |
| |
| Active Comparator: Arm 1B: IM ceftriaxone | Intramuscular ceftriaxone |
| |
| Active Comparator: Arm 2: IM benzathine penicillin G | Intramuscular benzathine penicillin G |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftriaxon | Drug | Ceftriaxone will not be provided as part of the study. Pregnant participants will receive these drugs as prescribed outside the study by their non-study clinical care provider |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimester | Arm 1A | First on-study dose through 24 hours |
| Geometric mean terminal elimination half-life (t1/2) in the first trimester | Arm 1A | First on-study dose through 24 hours |
| Geometric mean trough concentration (Ctrough) in the first trimester | Arm 1A | First on-study dose through 24 hours |
| Geometric mean AUC0-tau in the second trimester | Arm 1A | First on-study dose through 24 hours |
| Geometric mean t1/2 in the second trimester | Arm 1A | First on-study dose through 24 hours |
| Geometric mean Ctrough in the second trimester | Arm 1A | First on-study dose through 24 hours |
| Geometric mean AUC0-tau in the third trimester | Arm 1A | First on-study dose through 24 hours |
| Geometric mean t1/2 in the third trimester | Arm 1A | First on-study dose through 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a maternal serious adverse event (SAE) | Arm 1A and Arm 1B | First on-study dose through 7 days |
| Proportion of participants with a maternal SAE assessed as related to drug under study |
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Inclusion Criteria:
Is of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with Institutional Review Board (IRB) policies and procedures and is willing and able to provide written informed consent for her own and, if applicable (Arm 2), her infant's study participation
At screening, has a viable singleton intrauterine pregnancy of any gestational age confirmed by fetal ultrasound, as determined by the site investigator based on medical records, with trimester documented based on the best available obstetric estimate
At screening, is receiving or expected to receive one of the following drugs under study as prescribed by a clinical care provider and documented in medical records:
At entry, expects to remain in the geographic area of the study site during pregnancy and at least 30 days postpartum
Exclusion Criteria:
Previously enrolled in this study
Requires desensitization to ceftriaxone or benzathine penicillin G as determined by the site investigator based on pregnant participant report and available medical records
Has any of the following as determined by the site investigator based on pregnant participant report and available medical records:
Receipt of any of the following prohibited medications within seven days prior to entry as determined by the site investigator based on pregnant participant report and available medical records:
Arm 1A: any penicillin
Arm 1B: any penicillin
Arm 2: penicillin other than benzathine penicillin G
Receipt of any investigational agent within seven days prior to entry as determined by the site investigator based on pregnant participant report and available medical records
Has any documented or suspected clinically significant condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
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Women receiving or expecting to receive ceftriaxone for indications other than syphilis or benzathine penicillin G for treatment of syphilis during pregnancy in the United States (US). The infants of pregnant participants receiving benzathine penicillin G will also be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Levy | Contact | 2028848480 | impaact.ctgov@fstrf.org | |
| Lisa Levy | Contact | 2028848480 | llevy@fhi360.org |
| Name | Affiliation | Role |
|---|---|---|
| Jason Zucker | Columbia Physicians & Surgeons (P&S) CRS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 5048, USC - Maternal Child Adolescent/Adult Center | Not yet recruiting | Los Angeles | California | 90033 | United States |
Individual participant data that underlie results in the publication, after deidentification.
Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
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| Benzathine penicillin G | Drug | Benzathine penicillin G will not be provided as part of the study. Pregnant participants will receive these drugs as prescribed outside the study by their non-study clinical care provider |
|
| Geometric mean Ctrough in the third trimester | Arm 1A | First on-study dose through 24 hours |
| Median maximum plasma concentration during the dose interval (Cmax) in the first trimester | Arm 1B | First on-study dose through up to 24 hours |
| Median time to Cmax (Tmax) in the first trimester | Arm 1B | First on-study dose through up to 24 hours |
| Median Cmax in the second trimester | Arm 1B | First on-study dose through up to 24 hours |
| Median Tmax in the second trimester | Arm 1B | First on-study dose through up to 24 hours |
| Median Cmax in the third trimester | Arm 1B | First on-study dose through up to 24 hours |
| Median Tmax in the third trimester | Arm 1B | First on-study dose through up to 24 hours |
| Geometric mean AUC at 7 days (AUC 0-7d) in the first trimester | Arm 2 | First on-study dose through 7 days |
| Geometric mean AUC at 14 days (AUC0-14d) in the first trimester | Arm 2 | First on-study dose through 14 days |
| Geometric mean plasma concentration at 2 hours (C2h) in the first trimester | Arm 2 | 2 hours post-first on-study dose |
| Geometric mean plasma concentration at 24 hours (C24h) in the first trimester | Arm 2 | 24 hours post-first on-study dose |
| Geometric mean plasma concentration at 4 days (C4d) in the first trimester | Arm 2 | 4 days post-first on-study dose |
| Geometric mean plasma concentration at 7 days (C7d) in the first trimester | Arm 2 | 7 days post-first on-study dose |
| Geometric mean plasma concentration at 14 days (C14d) in the first trimester | Arm 2 | 14 days post-first on-study dose |
| Geometric mean AUC0-7d in the second trimester | Arm 2 | First on-study dose through 7 days |
| Geometric mean AUC0-14d in the second trimester | Arm 2 | First on-study dose through 14 days |
| Geometric mean C2h in the second trimester | Arm 2 (as defined above) | 2 hours post-first on-study dose |
| Geometric mean C24h in the second trimester | Arm 2 (as defined above) | 24 hours post-first on-study dose |
| Geometric mean C4d in the second trimester | Arm 2 (as defined above) | 4 days post-first on-study dose |
| Geometric mean C7d in the second trimester | Arm 2 (as defined above) | 7 days post-first on-study dose |
| Geometric mean C14d in the second trimester | Arm 2 (as defined above) | 14 days post-first on-study dose |
| Geometric mean AUC0-7d in the third trimester | Arm 2 | First on-study dose through 7 days |
| Geometric mean AUC0-14d in the third trimester | Arm 2 | First on-study dose through 14 days |
| Geometric mean C2h in the third trimester | Arm 2 (as defined above) | 2 hours post-first on-study dose |
| Geometric mean C24h in the third trimester | Arm 2 (as defined above) | 24 hours post-first on-study dose |
| Geometric mean C4d in the third trimester | Arm 2 (as defined above) | 4 days post-first on-study dose |
| Geometric mean C7d in the third trimester | Arm 2 (as defined above) | 7 days post-first on-study dose |
| Geometric mean C14d in the third trimester | Arm 2 (as defined above) | 14 days post-first on-study dose |
Arm 1A and Arm 1B
| First on-study dose through 7 days |
| Proportion of participants with a maternal SAE | Arm 2 | First on-study dose through up to 28 days |
| Proportion of participants with a maternal SAE assessed as related to drug under study | Arm 2 | First on-study dose through up to 28 days |
| Proportion of participants with a spontaneous abortion or miscarriage (<20 weeks gestation) | Arm 1A, Arm1B, and Arm 2 | At pregnancy outcome/delivery/birth |
| Proportion of participants with a stillbirth (≥20 weeks gestation) | Arm 1A, Arm1B, and Arm 2 | At pregnancy outcome/delivery/birth |
| Proportion of participants with an infant small for gestational age (SGA; weight <10th percentile for gestational age, adjusted for sex) | Arm 1A, Arm1B, and Arm 2 | At pregnancy outcome/delivery/birth |
| Proportion of participants with a preterm birth (<37 weeks gestation) | Arm 1A, Arm1B, and Arm 2 | At pregnancy outcome/delivery/birth |
| Proportion of participants with an infant congenital anomaly consistent with the definition of defect provided by Metropolitan Atlanta Congenital Defects Program (MACDP) | Arm 1A, Arm1B, and Arm 2 | At pregnancy outcome/delivery/birth |
| Site 5112, David Geffen School of Medicine at UCLA NICHD CRS | Recruiting | Los Angeles | California | 90095 | United States |
|
| Site 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRS | Not yet recruiting | Chicago | Illinois | 60612 | United States |
|
| Site 4001, Lurie Children's Hospital of Chicago (LCH) CRS | Recruiting | Chicago | Illinois | 60614 | United States |
|
| Site 5040, SUNY Stony Brook NICHD CRS | Recruiting | Stony Brook | New York | 11794 | United States |
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| Site 5114, Bronx-Lebanon Hospital Center NICHD CRS | Recruiting | The Bronx | New York | 10457 | United States |
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| Site 5013, Jacobi Med. Ctr. Bronx NICHD CRS | Not yet recruiting | The Bronx | New York | 10461 | United States |
|
| Site 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRS | Not yet recruiting | Houston | Texas | 77030 | United States |
|
| Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research CRS | Not yet recruiting | San Juan | 00935 | Puerto Rico |
|
| ID | Term |
|---|---|
| D013587 | Syphilis |
| ID | Term |
|---|---|
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| D010400 | Penicillin G |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010406 | Penicillins |
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