tobramycin injection / Generic mfg. - LARVOL DELTA

Tobramycin Injection to Prevent Infection in Open Fractures (clinicaltrials.gov) - P3 | N=600 | Completed | Sponsor: Massachusetts General Hospital | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Musculoskeletal Diseases • Orthopedics

CF-HEAR: Rates of Hearing and Vestibular Abnormalities in People with Cystic Fibrosis Exposed to Ototoxic Therapies (NACFC 2026) - "Participants included PwCF ages 6 years and older currently or recently prescribed an oral macrolide (azithromycin) and/or an inhaled or intravenous (IV) aminoglycoside (amikacin or tobramycin)...In the three years prior to enrollment, 89% of PwCF were prescribed chronic azithromycin, 38% inhaled tobramycin, and 15% IV tobramycin... Utilizing a standardized screening approach for testing hearing and vestibular abnormalities in PwCF exposed to ototoxic medications, we identified a significantly higher proportion of PwCF with abnormalities than is reported in CF Foundation patient registry data. As the lifespan of PwCF continues to increase, this underscores the vital importance of a standardized, easily accessible approach to assessing this in PwCF to identify opportunities for intervention to improve quality of life."

Cystic Fibrosis • Genetic Disorders • Immunology • Otorhinolaryngology • Respiratory Diseases

Pharmacokinetic analysis of conventional tobramycin dosing for infants in the cardiac intensive care unit. (PubMed, Pediatr Res) - "Tobramycin pharmacokinetic data are limited in infants with congenital heart disease (CHD). A dosing regimen of 3.5 mg/kg/dose every 12 hours for intravenous tobramycin achieves therapeutic targets in infants aged 1 month to 1 year with CHD in the cardiac intensive care unit (CICU). Infants with estimated glomerular filtration rates <90 mL/min/1.73 m2 required dose adjustments to meet targets at adequate rates. This study aimed to characterize the pharmacokinetics of tobramycin in infants in the CICU, highlighting weight and renal function as significant covariates for individualized dosing."

Journal • PK/PD data • Cardiovascular • Critical care • Heart Failure

Tobramycin pharmacokinetic and pharmacodynamic targets in people with cystic fibrosis. (PubMed, Br J Clin Pharmacol) - "Intravenous tobramycin is a first-line treatment for Pseudomonas aeruginosa infection in people with cystic fibrosis (CF)...Current therapeutic Cmax (20-40 mg/L) and Cmin (<1 mg/L) targets remain appropriate. Evidence suggests AUC24-guided dosing for improved efficacy and safety; however, further research is needed to confirm the optimal AUC24 target (80-120 mg/L·h)."

Journal • PK/PD data • Review • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

OPTIMAL: A multicentre pilot feasibility randomised controlled trial of multidrug-resistant organism-guided antibiotic prophylaxis and a fixed five-day duration of antifungal prophylaxis in liver transplant recipients. (ANZCTR) - P=N/A | N=210 | Recruiting | Sponsor: Austin Health | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2026

Enrollment open • Trial initiation date • Infectious Disease • Transplantation

Community-acquired carbapenem-resistant Acinetobacter baumannii pneumonia in an elderly woman with chronic kidney disease: A case report. (PubMed, IDCases) - "She was successfully treated with intravenous tobramycin and levofloxacin, followed by oral doxycycline and levofloxacin. Clinical and radiologic resolution was achieved by week 6. This case highlights a rare instance of community-acquired CRAB pneumonia and underscores the importance of BAL-based diagnosis and susceptibility-guided therapy, particularly in high-risk patients."

Journal • Chronic Kidney Disease • Infectious Disease • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases

OPTIMAL: A multicentre pilot feasibility randomised controlled trial of multidrug-resistant organism-guided antibiotic prophylaxis and a fixed five-day duration of antifungal prophylaxis in liver transplant recipients. (ANZCTR) - P=N/A | N=210 | Not yet recruiting | Sponsor: Austin Health

New trial • Infectious Disease • Transplantation

Systemic Ebselen Treatment Prevents Amikacin Induced Ototoxicity and Nephrotoxicity in Mice (ARO 2026) - "Background : Aminoglycosides (AGs), such as tobramycin and amikacin, commonly used to treat recurrent pulmonary infections, are ototoxic and nephrotoxic. 28-days of amikacin increased the severity and duration of ototoxicity that was significantly reduced by ebselen. Amikacin-induced nephrotoxicity (increased Cr) was significantly reduced by ebselen. Interestingly, no hyperacusis was observed in any group and may be a consequence of greater PTS."

Preclinical • Infectious Disease • Nephrology • Otorhinolaryngology • Respiratory Diseases

Optimization of Intravenous Tobramycin Therapeutic Drug Monitoring in Pediatric Patients With Cystic Fibrosis (ASHP 2025) - No abstract available

Clinical • Cystic Fibrosis • Genetic Disorders • Immunology • Pediatrics • Respiratory Diseases

Alembic Pharmaceuticals Ltd… said it has received final approval from the US health regulator for its generic version of Loteprednol Etabonate and Tobramycin ophthalmic suspension used for treatment of eye infection. (The Hindu Business Line) - "The approval granted by the US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension of strength 0.5 per cent/0.3 per cent (5 mL and 10 mL), Alembic Pharmaceuticals Ltd said in a regulatory filing...Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialisation, it added."

ANDA • Infectious Disease • Ocular Inflammation

BEAT CF DSA B - Adjunct antibiotics: BEAT CF: Pulmonary Exacerbations Treatment Platform - Adjunct Antibiotics Domain (ANZCTR) - P=N/A | N=500 | Terminated | Sponsor: University of Sydney | N=5000 ➔ 500 | Recruiting ➔ Terminated

Enrollment change • HEOR • Trial termination • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Characteristics, treatment, and lung function outcomes of pulmonary exacerbations in cystic fibrosis: insights from the BEAT-CF cohort. (PubMed, Eur Respir J) - "The pattern and magnitude of lung function impairment during PERITs is similar among those receiving and not receiving modulator therapy. This underscores the continued need for evidence to help clinicians balance treatment burden against the risk of irreversible loss of lung function."

Journal • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

Changes in Medicaid claims for chronic medications for cystic fibrosis (NACFC 2025) - "Background: Several published reports have described changes in chronic medications for cystic fibrosis (CF) after the initiation of elexacaftortezacaftor-ivacaftor (ETI)...Prescriptions for inhaled tobramycin were difficult to differentiate from prescriptions for IV tobramycin, so we have not yet included tobramycin in our analysis... Prescriptions for dornase alfa and inhaled aztreonam decreased after the introduction of ETI, but to a greater extent than recorded in the CFFPR (approximately 15% and 25%, respectively). These results support the use of claims data to complement CFFPR analyses and prospective studies to understand changes in chronic CF medications use after ETI. Our analysis is limited by the inability to examine only people with CF, to determine if people with CF took the medications that were prescribed, or whether changes in medications occurred via shared decision-making with the CF care team."

Medicaid • Reimbursement • US reimbursement • Cystic Fibrosis • Genetic Disorders • Immunology • Respiratory Diseases

Tobramycin Injection to Prevent Infection in Open Fractures (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: Massachusetts General Hospital | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Musculoskeletal Diseases • Orthopedics

Personalized tobramycin dosing in children with cystic fibrosis: an AUC24-guided approach. (PubMed, Antimicrob Agents Chemother) - "Multicenter prospective observational study of children with CF aged 0-19 years receiving IV tobramycin who had ≥1 serum concentration measured...A fully individualized approach (available at https://www.kidscalc.org/) improved target attainment in all children. CFTR modulators had a negligible effect on tobramycin PK."

Journal • Cystic Fibrosis • Genetic Disorders • Immunology • Pulmonary Disease • Respiratory Diseases • CFTR

Tobramycin Injection to Prevent Infection in Open Fractures (clinicaltrials.gov) - P3 | N=600 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Sep 2025 ➔ Aug 2026 | Trial primary completion date: Sep 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Infectious Disease • Musculoskeletal Diseases • Orthopedics

A case report of late-onset central toxic keratopathy following femtosecond laser-assisted in situ keratomileus. (PubMed, BMC Ophthalmol) - "Early and correct differentiation between CTK and DLK could lead to a good prognosis. Corneal confocal microscopy is helpful in diagnosis. A reduction in the use of corticosteroids and antibiotics led to further ocular amelioration. Moreover, this treatment should actively promote corneal epithelial repair, and in the future, the use of vitamin C in the early stage of the disease can be considered."

Journal • Keratitis • Ocular Inflammation • Ophthalmology • Pain

Calcineurin Inhibitors Not Always to Blame: Case of Inhaled Tobramycin Nephrotoxicity in Lung Transplant (ISHLT 2025) - "Bronchoscopy cultures grew Serratia marcescens on POD 16 which was treated with intravenous (IV) cefepime and meropenem...However, with increased congestion and cough, oral levofloxacin started POD 170...A serum tobramycin trough level was elevated at 4.1 µg/mL, more than twice the recommended trough for IV tobramycin (<1-2 µg/mL). ITS was stopped POD 260, levels POD 263 and 265 decreased to 1.5 µg/mL and 1.0 µg/mL respectively and renal function started to improve.Summary Renal dysfunction with ITS is thought to be minimal, but this case demonstrates systemic absorption and supratherapeutic trough levels, which contributed to drug accumulation and AKI in a LT recipient. Evaluating trough tobramycin levels while on ITS should be considered in LT pts with declining renal function and repeat levels may be considered as drug clearance may be prolonged."

Clinical • Acute Kidney Injury • Cough • Infectious Disease • Interstitial Lung Disease • Nephrology • Pneumonia • Respiratory Diseases • Transplantation

Relationship between Sputum Bacterial Load and Lung Function in Children with Cystic Fibrosis Receiving Tobramycin. (PubMed, Respir Med) - "A greater reduction in total sputum P. aeruginosa bacterial load (live+dead) was associated with improved lung function (FEV1) in children with CF receiving tobramycin."

Journal • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Effectiveness of Single-Stage Debridement with High-Dose Medullary Antibiotic Injection for Treating Osteomyelitis (AAOS 2025) - "The surgical technique included local debridement and medullary debridement using a reamer irrigator, with injection of 30 mL of calcium sulfate in the canal using a french tube and a tumi syringe, mixed with 9g of Vancomycin and 3.6g of Tobramycin... Surgical debridement and high dose antibiotic injection can be an effective and safe way to treat Cierny stage III and IV osteomyelitis. The surgeon must be vigilant for renal function postoperatively when injecting antibiotics in the medullary canal."

Acute Kidney Injury • Infectious Disease • Inflammation • Nephrology • Renal Disease

SYSTEMIC ACCUMULATION OF TOBRAMYCIN INHALATION (SATIN) STUDY (SCCM 2025) - "Introduction: The relationship between intravenous tobramycin and acute kidney injury (AKI) has been established in previous studies. Currently, the package insert does not report nephrotoxicity from inhaled tobramycin but does suggest obtaining levels if given with other nephrotoxic agents. However, our data suggests a statistically significant risk of renal injury that increases by 17% with each additional accumulating dose of inhaled tobramycin. As data is lacking for inhaled tobramycin dose adjustments, we recommend frequent monitoring with troughs and dose re-evaluation for safe and effective regimens."

Acute Kidney Injury • Genetic Disorders • Immunology • Infectious Disease • Nephrology • Non‐Cystic Fibrosis Bronchiectasis • Pneumonia • Renal Disease • Respiratory Diseases

INHALED VERSUS IV TOBRAMYCIN FOR EMPIRIC GRAM-NEGATIVE COVERAGE IN VENTILATOR-ASSOCIATED PNA (SCCM 2025) - "There was no significant difference in treatment success between INHt and IVt for empiric treatment of VAP. Further research is warranted to establish the role of aerosolized antibiotics in the treatment of VAP."

Gram negative • Acute Kidney Injury • Infectious Disease • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases

Tobramycin Pharmacokinetics in Pediatric Patients With Primary Ciliary Dyskinesia. (PubMed, Pediatr Pulmonol) - "No difference in tobramycin elimination rate constant was found between patients with PCD and those with CF. Clinical outcomes were not significantly different between groups. Although not statistically significant, a lower tobramycin dose was observed in patients with PCD."

Journal • PK/PD data • Retrospective data • Acute Kidney Injury • Cystic Fibrosis • Genetic Disorders • Immunology • Nephrology • Otorhinolaryngology • Pediatrics • Pulmonary Disease • Renal Disease • Respiratory Diseases

Inhaled versus intravenous tobramycin therapy for empiric double Gramnegative coverage in pneumonia A single health system retrospective cohort study (ASHP 2024) - No abstract available

Gram negative • Retrospective data • Infectious Disease • Pneumonia • Respiratory Diseases

Real-word effectiveness of a Pseudomonas aeruginosa eradication protocol in children with cystic fibrosis (NACFC 2024) - "Eradication of new-onset P. aeruginosa infection with the use of 28 days of tobramycin inhaled solution (TIS) is recommended [1] and was found to be successful in 92% of cases 1 month after treatment and remained successful in 66% of cases at the final visit [2]...Step 1 consists of nebulized intravenous tobramycin 80 mg twice daily for 28 days and oral ciprofloxacin 40 mg/kg per day for 21 days... Our findings suggest that CHUSJ clinic multistage protocol for eradicating P. aeruginosa in people with CF is unconventional but effective. Our overall success rate compares with published data [2, 3]. Nonetheless, patient advocacy is required to facilitate access to recommended medication."

Clinical • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pediatrics • Respiratory Diseases