Clinical trials: Neonatal Infections
Tuberculosis
Study to Evaluate Safety and Immunogenicity of VPM1002 in Comparison With BCG in Newborn Infants in South Africa
Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis (TB) for residents in endemic areas…
- Trial name
- NCT01479972
- Testing
- VPM1002, BCG
- Where
- South Africa
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
Hepatitis C Virus Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4…
- Trial name
- NCT02301936
- Testing
- LDV/SOF
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Gilead Sciences
Acute Bacterial Infections, Acute Viral Infections
300 Antibody Diagnostic Test Kit
For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections.
- Trial name
- Antibody 300 (NCT01646411)
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- The Plasma Source
Cystic Fibrosis
Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF
The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic…
- Trial name
- AZLI CAT (NCT01641822)
- Testing
- AZLI, Tobramycin inhalation solution
- Where
- 71 sites in United States
- Volunteers
- 107 people
- Sponsor
- Gilead Sciences
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Hidradenitis Suppurativa, Atopic Dermatitis
A Study to Assess Molecular Changes in Adult Participants With Moderate to Severe Hidradenitis Suppurativa or With Moderate to Severe Atopic Dermatitis Receiving Subcutaneous Injections of Lutikizumab
Hidradenitis suppurativa (HS) and atopic dermatitis (AD) are chronic inflammatory skin diseases that lead to the development of skin lesions and symptoms such as pain and discomfort.
- Trial name
- NCT06524635
- Testing
- Lutikizumab
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- AbbVie
Plasmodium Falciparum Malaria
Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria
The purpose of this study was to evaluate PK, safety, tolerability and efficacy of a new formulation of artemether-lumefantrine dispersible tablet in neonates and infants <5 kg body weight with acute uncomplicated Plasmodium…
- Trial name
- CALINA (NCT04300309)
- Testing
- artemether:lumefantrine (2.5 mg:30 mg)
- Where
- 3 sites in Burkina Faso, Democratic Republic of the Congo
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Tuberculosis
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
The objective of this project is to demonstrate safety, immunogenicity and improved efficacy of the new live attenuated M. tuberculosis vaccine called MTBVAC in a Phase 3 efficacy trial in HIV-uninfected infants born to…
- Trial name
- MTBVACN3 (NCT04975178)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 7,120 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Cystic Fibrosis
Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000
The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.
- Trial name
- MAESTRALE (NCT01651455)
- Where
- Italy
- Volunteers
- 92 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Atopic Dermatitis, Dermatology
A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions
The primary goal of the study is to collect standardized patient and clinician reported outcome measures for patients diagnosed with a range of dermatological conditions in an academic clinical practice setting.
- Conditions
- Atopic Dermatitis, Dermatology, Vitiligo, Alopecia Areata
- Trial name
- ClinPRO-DERM (NCT05084417)
- Testing
- N/A This is an observational study
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- OM1, Inc.
Human Papillomavirus Infections
GARDASIL™ Vaccine Impact in Population Study (V501-033)
This study will assess the impact of GARDASIL™ human papillomavirus (HPV) vaccine in the general female population by utilizing nationwide registry databases in the participating Nordic countries.
- Trial name
- VIP (NCT01077856)
- Volunteers
- 54,516 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)
A Study of the Safety and Tolerability in Participants With PIK3CA-related Overgrowth Spectrum or Proteus Syndrome Who Are Being Treated With Miransertib (MK-7075) in Other Studies (MK-7075-006)
This is a study of the safety and tolerability of oral miransertib (MK-7075) administered to participants at least 2 years of age with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-related…
- Trial name
- NCT04980872
- Testing
- Miransertib
- Where
- 11 sites in United States, Australia and 3 more
- Volunteers
- 60 people
- Sponsor
- Merck Sharp & Dohme LLC
Cancer
BCX-1777 in Treating Patients With Refractory Cancer
RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer.
- Trial name
- NCT00073944
- Testing
- forodesine hydrochloride
- Where
- United States
- Sponsor
- BioCryst Pharmaceuticals
Atopic Dermatitis
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
- Trial name
- NCT00316602
- Testing
- IMVAMUNE
- Where
- 22 sites in United States, Mexico
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF2 (NCT00104520)
- Testing
- AZLI 75 mg two times a day (BID)/three times a day (TID)
- Where
- 56 sites in United States
- Volunteers
- 211 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection
The purpose of this study is to evaluate the safety and efficacy of 2 dose combinations of fosfomycin/tobramycin for inhalation (FTI), following a 28-day course of Aztreonam for Inhalation (AZLI) in patients with cystic fibrosis…
- Trial name
- NCT00794586
- Testing
- FTI, AZLI
- Where
- 36 sites in United States
- Volunteers
- 120 people
- Sponsor
- Gilead Sciences
Advanced Solid Tumor
A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors
This is a study to evaluate the safety and potential anti-tumor activity of an investigational drug called ARV-6723, in participants with advanced solid tumors.
- Trial name
- NCT07749586
- Testing
- ARV-6723, Pembrolizumab, SOC
- Where
- 4 sites in United States
- Volunteers
- 499 people
- Sponsor
- Arvinas Inc.
Pertussis
Assessing Contacts' Decision Making on Reducing the Risk of Pertussis Transmission to Newborns Through Immunisation
This study aims to establish an effective method to inform parents or close relatives of newborns about the risk of pertussis transmission to newborns and the advantages offered by the cocooning strategy (vaccinating those who…
- Trial name
- NCT01890447
- Testing
- Web-based survey questionnaire
- Where
- 9 sites in Italy, Spain
- Volunteers
- 676 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection.
- Trial name
- NCT01473264
- Testing
- recombinant human CC10 (rhCC10)
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Clarassance, Inc.
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.
- Trial name
- EARLY (NCT01082367)
- Testing
- TOBI
- Where
- 19 sites in Canada, Egypt and 8 more
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals