Studies In Progress

Short Name Title Study Description Start Date Status
PROPEL Phase 1, prospective, multi-center, randomized study to evaluate the epithelial lining fluid (ELF) penetration of a novel Gram-negative agent in patients with nosocomial pneumonia Evaluation of novel Gram-negative agent in patients with nosocomial pneumonia 5/12/2016 Protocol development
ADAPT Platform study for antibacterials Developing a platform trial (Master or Common Protocol) design for antibacterials

http://www.berryconsultants.com/antibiotic-platform-design/

9/10/15 Simulations complete; manuscript in progress
PAD Multi-dose PK of oral fosfomycin Companion study to FOCUS 9/10/15 Planning
NICE Novel endpoint for cUTI Companion study to FOCUS 7/9/15 Planning
RAPIDS-GN Rapid diagnostics for GNB in blood Effect of use of 2 rapid diagnostics for GNB on outcomes 7/9/15 Protocol Development
CEPCON Sample collection protocol Oral and rectal healthy matrix sample collection for NG/CT test 6/11/15 Protocol Development (Final stage)
PROOF PK of oral fosfomycin PK study of three dose regimens of oral fosfomycin in healthy volunteers 5/29/15 Enrollment complete. Database locked. Analysis in progress.
DOTS Oral stepdown for S. aureus Bacteremia Oral stepdown for S. aureus bacteremia

DOOR Reading Materials

5/14/15 Protocol Development
FOCUS Oral stepdown for cUTI Oral stepdown for cUTI 4/9/15 Protocol Development
CEP-VAP Rapid diagnostic for VABP Rapid diagnostic to detect gram positive and negative organisms in VABP patients directly in BAL and ETA samples 3/12/15 Complete
STAR Microbiome analysis Companion study to SCOUT-CAP 1/7/15 Protocol finalized; IRB submissions complete.
TRAP Use of PCT testing to direct antibiotic use in lower respiratory tract infections (LRTI) Comparison of outcomes of antibiotic vs placebo treatment in LRTI patients with low procalcitonin levels 1/7/15 Protocol Development
GC MASTER PROTOCOL Gonorrhea and chlamydia master protocol for diagnostics Evaluate diagnostics for extragenital gonorrhea and chlamydia 1/7/15 Protocol Development complete. 1st patient estimated March 2017.
MASTER PROTOCOL Master Protocol for Diagnostic Studies Develop Master Protocol for Diagnostic Studies What is a MASTERMIND Study FINAL 13-Jan-17 12/4/14 Planning
CREST Carbapenem-resistant Enterobacteriaceae in solid organ transplant patients Using novel molecular beacons to study the impact of carbapenem resistant Enterobacteriaceae (CRE) carriage on the outcomes of solid organ transplantation (SOT) 10/9/14 Enrollment complete. Analysis complete. Manuscript in progress.
CRKP-LTACH ESI seed grant Carbapenem-resistant Klebsiella pneumoniae in Long Term Acute Care Hospitals  8/12/14 Data complete. Analysis in progress.
CEPCRO Rapid diagnostic for carbapenem resistant organisms Rapid diagnostic test to detect carbapenem-resistant organisms directly in respiratory and urine samples 6/12/2014 Complete
RADICAL Bacterial vs viral diagnostic Validation of two platforms for diagnosis of bacterial vs viral acute respiratory infection 5/7/2014 Enrollment complete
PROVIDE Vanc PK/PD in MRSA bacteremia Determine if vancomycin AUC/MIC is related to outcome in MRSA bacteremia 5/7/2014  Enrollment complete
SCOUT-CAP Short course therapy in pediatric CAP Short course therapy in pediatric CAP 5/7/2014 First patient enrolled December 2016
CEF-BP ESI seed grant Multi-center gram negative database to establish clinically relevant antibiotic breakpoint interpretive criteria for ceftriaxone 4/10/2014 Data collection almost complete
BCID ESI seed grant Clinical and economic outcomes of BCID test use 12/17/2013 Data collection complete.  Analysis complete

Manuscript in CID.

CRACKLE CRKP consortium Carbapenem-resistant Klebsiella pneumoniae in Hospitalized Patients 12/6/2013 Complete; multiple publications
DICON1 Antimicrobial stewardship effectiveness in the community hospital setting A cluster randomized, crossover trial to compare the effectiveness of two interventions (formulary restriction and preauthorization vs prospective audit) on targeted antibiotic use in community hospitals 8/1/2013 Analysis complete; Manuscript in progress. DICON II cancelled.
NICU-AR Data mining antibacterial resistance studies in NICU patients Gram negative infections in NICU patients plus vancomycin use in MRSA, MSSA, CoNS 8/1/2013 Complete
PRIMERS Rapid genotyping of MDR-GNB Develop a cost efficient platform to rapidly identify antibiotic resistant gram negative bacteria 6/1/2013 PRIMERS I-IV complete.