Clinical trials: Newborn; Infection
Cystic Fibrosis
Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa.
- Trial name
- NCT01316276
- Testing
- Liposomal amikacin for inhalation
- Where
- 50 sites in Austria, Belgium and 15 more
- Volunteers
- 206 people
- Sponsor
- Insmed Incorporated
Infections, Rotavirus
Study of a Birth Dose of GlaxoSmithKline Biologicals' 251154 Vaccine
The purpose of the study is to evaluate the safety and immunogenicity of a birth dose of GSK Biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.
- Trial name
- NCT01110044
- Testing
- 251154 vaccine, Infanrix hexa™, Synflorix™
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa
The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary…
- Trial name
- NCT00757237
- Testing
- Aztreonam for Inhalation Solution (AZLI), Tobramycin Inhalation Solution (TIS)
- Where
- 92 sites in United States, Austria and 11 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
Crohn Disease, Ulcerative Colitis
Expanded Access to Upadacitinib
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility.
- Conditions
- Crohn Disease, Ulcerative Colitis, Idiopathic Arthritis (Including sJIA, pJIA, or JPsA), Atopic Dermatitis
- Trial name
- NCT04159597
- Testing
- Upadacitinib
- Sponsor
- AbbVie
Bacterial Conjunctivitis
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days…
- Trial name
- NCT01330355
- Testing
- Besivance, Gatifloxacin
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Bausch & Lomb Incorporated
Cystic Fibrosis, Pseudomonas Aeruginosa Airway Infection
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P.
- Trial name
- NCT00499720
- Testing
- Aztreonam Lysine for Inhalation
- Where
- 65 sites in United States, Puerto Rico
- Sponsor
- Gilead Sciences
Microcephaly
Zika and Microcephaly: Case-control Study
It is suspected that zika virus infection during pregnancy is associated with microcephaly. The objective of this study is to investigate the occurrence of rash accompanied by three or more dengue-like signs and symptoms during…
- Trial name
- NCT02741882
- Testing
- Questionary
- Where
- Brazil
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Laboratório Sabin
Lung Cancer, Lung Infection
Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath
The goal of this observational study is to develop an advanced expiratory algorithm model utilizing exhaled breath volatile organic compound (VOC) marker molecules.
- Conditions
- Lung Cancer, Lung Infection, COPD, Bronchitis
- Trial name
- NCT06528418
- Testing
- Gas chromatography-mass spectrometry(GC-MS) and micro Gas Chromatography-photoionisation detector (μGC-PID) system
- Where
- China
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- ChromX Health
HIV-1-infection
Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV
The goal of this clinical study is to learn more about the study drug, Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), safety, tolerability, and pharmacokinetics (how B/F/TAF is absorbed, modified, distributed, and…
- Trial name
- NCT07055451
- Testing
- B/F/TAF
- Where
- 7 sites in United States, South Africa
- Volunteers
- 16 people
- Sponsor
- Gilead Sciences
Respiratory Tract Infections
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
- Trial name
- DAISY (NCT04583280)
- Testing
- Rilematovir, Rilematovir X mg/kg
- Where
- 142 sites in United States, Argentina and 24 more
- Volunteers
- 28 people
- Sponsor
- Janssen Research & Development, LLC
Chronic Inflammatory Demyelinating Polyneuropathy, Guillain-Barre Syndrome
RWE-based Treatment Patterns and Outcomes in CIDP
To describe the demographics, clinical characteristics, treatment patterns and clinical outcomes of chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barre Syndrome (GBS), and heredofamilial amyloidosis (hATTR)…
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, Guillain-Barre Syndrome, Hereditary Amyloidosis
- Trial name
- NCT05940922
- Testing
- No intervention. Retrospective observation only.
- Where
- United Kingdom
- Volunteers
- 170 people
- Sponsor
- RwHealth
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
Cytomegalovirus Retinitis, HIV Infections
The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of cytomegalovirus retinitis in patients with AIDS.
- Trial name
- NCT00002299
- Testing
- Interferon beta-1b, Ganciclovir
- Where
- 6 sites in United States
- Sponsor
- Hoffmann-La Roche
Hepatitis B
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™.
- Trial name
- NCT00240539
- Testing
- Blood sampling
- Where
- Thailand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease.
- Trial name
- NCT01155193
- Volunteers
- 30,804 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Cytomegalovirus Infections, HIV Infections
Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
To provide ganciclovir on a compassionate use basis to immunocompromised patients with serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient population.
- Trial name
- NCT00002024
- Testing
- Ganciclovir
- Where
- United States
- Sponsor
- Hoffmann-La Roche
Hunter Syndrome
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter…
- Trial name
- AIM-IT (NCT02055118)
- Testing
- idursulfase-IT, No IT treatment
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 58 people
- Sponsor
- Shire
Acute Uncomplicated Falciparum Malaria
Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
- Trial name
- NCT01619878
- Testing
- Artemether-lumefantrine (COA566)
- Where
- 7 sites in Benin, Burkina Faso and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
COVID-19, Pregnant Women
Qatar PREgnancy Covid-19 OUtcome Study
The in-utero exposure of acute viral infection in some instances is proven to have short- and long-term neonatal effects during the postnatal and childhood period and the Zika virus, measles, mumps, and rubella are few examples.
- Trial name
- QPRECIOUS (NCT05349279)
- Where
- Qatar
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Hamad Medical Corporation
Hepatitis B
Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns
The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their…
- Trial name
- NCT01349283
- Testing
- HepavaxGene (thiomersal free), Engerix B
- Where
- China
- Volunteers
- 1,738 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV