Clinical trials: Pregnancy; Infection
COVID-19
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
The purpose of this study is to learn about the side effects (safety) of the study medicine PF-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate COVID-19 infection in adults with severe renal impairment.
- Trial name
- NCT05487040
- Testing
- PF-07321332 (nirmatrelvir)/ritonavir
- Where
- 52 sites in United States
- Volunteers
- 15 people
- Sponsor
- Pfizer
Respiratory Tract Infections, Urinary Tract Infections
TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis
This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin \& soft tissue infections; or suspected…
- Conditions
- Respiratory Tract Infections, Urinary Tract Infections, Intra-Abdominal Infections, Skin and Soft Tissue Infection
- Trial name
- SEPSIS-SHIELD (NCT04094818)
- Testing
- TriVerity
- Where
- 26 sites in United States, Greece
- Volunteers
- 1,441 people
- Sponsor
- Inflammatix
Recurrent Genital Herpes
Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
This is a phase III, multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed by 250 mg 12-hourly) to standard five-day…
- Trial name
- NCT00171990
- Testing
- Famciclovir
- Where
- Australia
- Volunteers
- 1,461 people
- Sponsor
- Novartis
Herpes Simplex Type 2
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
The purpose of this study is to evaluate the effect of recombinant human heat shock protein 70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital herpes by evaluating viral shedding before…
- Trial name
- NCT01687595
- Testing
- HerpV and QS-21
- Where
- 5 sites in United States
- Volunteers
- 80 people
- Sponsor
- Agenus Inc.
COVID-19
A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.
The purpose of the study is to learn about: how PF-07817883 is processed in the body of adult participants. the safety of PF-07817883.
- Trial name
- NCT06586216
- Testing
- PF-07817883
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Lymphoma
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)
To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter…
- Trial name
- NCT03098589
- Testing
- Revlimid
- Where
- Japan
- Volunteers
- 1,149 people
- Sponsor
- Celgene
Pregnant
DV2-HBV-27: Observational Pregnancy Registry
Purpose of the study is to evaluate pregnancy outcomes among women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy
- Trial name
- HBV-27 (NCT03664648)
- Testing
- HEPLISAV-B
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Melanoma, Merkel Cell Carcinoma
REVEAL Study of NKTR-262 in Combination With NKTR-214 and Nivolumab in Patients With Locally Advanced / Metastatic Solid Tumor Malignancies
Patients received intratumoral (IT) injections of NKTR-262 in 3-week cycles for up to 3 cycles; bempegaldesleukin with or without nivolumab was administered every 3 weeks (q3w), and treatment continued until unacceptable…
- Conditions
- Melanoma, Merkel Cell Carcinoma, Triple Negative Breast Cancer, Head and Neck Squamous Cell Carcinoma
- Trial name
- REVEAL (NCT03435640)
- Testing
- NKTR-262, bempegaldesleukin, nivolumab
- Where
- 14 sites in United States
- Volunteers
- 64 people
- Sponsor
- Nektar Therapeutics
Group B Streptococcal Infections
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
To assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen, at three dosage levels in healthy, non-pregnant, adult women of childbearing age (WOCBA).
- Trial name
- NCT06611371
- Testing
- IVT GBS-06
- Where
- 2 sites in United States, South Africa
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.
Vaginal Odor
Efficacy of (WaterWorks®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis
Comparing the new Stainless Steel WaterWorks® douching device to a commercially available douching device using just water for safety and efficacy of odor abatement.
- Trial name
- NCT00417365
- Testing
- WaterWorks Douching Device
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abbott Research Group
Respiratory Syncytial Virus Infections
A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.
The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA).
- Trial name
- NCT05045144
- Testing
- RSVPreF3(120 μg), Flu Quadrivalent influenza vaccine (15 μg HA)
- Where
- 36 sites in United States, Canada and 3 more
- Volunteers
- 1,586 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bacterial Vaginosis
A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis
This is a phase II multicenter randomized open-label clinical study that will determine whether treatment with Lactofiltrum (orally administered tablets) in combination with antibiotic therapy (metronidazole) is effective in…
- Trial name
- LF-BV-09 (NCT01089348)
- Testing
- Lactofiltrum + Metronidazole, Metronidazole
- Where
- 2 sites in Russia
- Volunteers
- 90 people
- Sponsor
- Avva Rus, JSC
Urinary Tract Infection
Cipro® XR in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections
The primary objective of this clinical trial was to determine the time to improvement of the signs and symptoms (eg, dysuria, frequency, urgency, gross hematuria, suprapubic pain, hesitancy, low back pain) of acute…
- Trial name
- NCT00676533
- Testing
- Cipro XR (Ciprofloxacin, BAYQ3939)
- Where
- 40 sites in United States
- Volunteers
- 276 people
- Sponsor
- Bayer
Infections, Papillomavirus
Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age
Human papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18)…
- Trial name
- NCT00492544
- Testing
- Cervarix™ (HPV-16/18 L1 VLP AS04)
- Where
- 5 sites in Japan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pregnant Women, Influenza
Flucelvax Pregnancy Registry
The goal of the registry is to develop a better understanding of the safety of Flucelvax in women and their offspring who were exposed to the vaccine during pregnancy
- Trial name
- NCT02258178
- Testing
- Flucelvax (cTIV)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Seqirus
Respiratory Tract Infections, Urinary Tract Infections
Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary System Infection
In the proposed study, the investigators plan to evaluate the efficacy and safety of Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.
- Trial name
- PIP-SBT (NCT01760109)
- Testing
- Piperacillin Sodium and Sulbactam Sodium
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Xiangbei Welman Pharmaceutical Co., Ltd
Urinary Tract Infections
Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli
Study LBx-1001 is a multi-center randomized, double-blind study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LBP-EC01 in patients with indwelling urinary catheters, or requiring…
- Trial name
- NCT04191148
- Testing
- LBP-EC01
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Locus Biosciences
Infections, Bacterial
Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function
This study will be conducted to determine if altered renal function affects the plasma pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal impairment are required.
- Trial name
- NCT02729038
- Testing
- Gepotidacin
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pregnancy, Malaria
Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
This study is a prospective observational study in which a female patient who received IV Artesunate while pregnant can volunteer to provide information about her pregnancy and the outcome of her pregnancy.
- Trial name
- NCT05285735
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Amivas Inc.
Pneumonia, Bacterial, Nosocomial Infection
A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
The purpose of this study is to assess the safety and effectiveness of doripenem treatment among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections, and complicated urinary tract infection.
- Conditions
- Pneumonia, Bacterial, Nosocomial Infection, Intraabdominal Infections, Urinary Tract Infection
- Trial name
- NCT01763008
- Testing
- No intervention
- Where
- 4 sites in Philippines
- Volunteers
- 170 people
- Sponsor
- Janssen Pharmaceutica