Randomized Controlled Trial Comparing Long and Short Duration of Antibiotic Prophylaxis for Patients Undergoing Sinus Lift Surgery
NCT ID: NCT02764710
Last Updated: 2016-05-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE3
Total Enrollment
250 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-05-31
Study Completion Date
2018-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The optimal use of prophylactic antibiotic therapy to prevent infection after sinus lift and augmentation surgery is unknown. This is a comparative open label interventional trial comparing a standard 7-day course of postoperative treatment with amoxicillin-clavulanate with short antibiotic treatment for up to 24 hours postoperatively. The primary study outcome is the postoperative surgical site infection in the standard versus the short treatment arms. Secondary outcomes are drug-related adverse events and Clostridium difficile infection.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CHOOSE : Telithromycin, Acute Bacterial Sinusitis
NCT00174694
Sinusitis
COMPLETED
PHASE4
A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses
NCT00249210
Sinusitis
Maxillary Sinusitis
COMPLETED
PHASE3
Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate
NCT03431337
Sinusitis, Acute
TERMINATED
PHASE4
A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.
NCT00236652
Maxillary Sinusitis
COMPLETED
PHASE3
Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
NCT01032174
Maxillary Sinusitis
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Research rational
The use of antibiotics as prophylaxis for surgical site infection (SSI) is well based in most fields of surgery. The use of prophylactic antibiotics can reduce the rate of post-surgical infections substantially. Nonetheless, overuse of these drugs is likely to expose patients to adverse effects, increase the rate of microbial drug resistance and lead to unnecessary expenses.
In the field of dentistry there are recommendations for prevention of infective endocarditis. The use of antibiotics for SSI in the field of oral and maxillofacial surgery is not well established, with inconsistent and even contradictory recommendations.
Sinus floor lift and augmentation is a common surgical procedure in modern dentistry. It aims to increase the amount of bone in the posterior maxilla, in the area of the premolar and molar teeth, prior to placement of dental implants. The procedure is performed in a per-oral approach; a mucoperiosteal flap is elevated, the lateral boney wall of the sinus is exposed and a window is cut with a surgical bur. The Schneiderian membrane (sinus periost) is separated and lifted from the bone and a bone graft material is placed into the newly created space. The graft material used can be an autograft, an allograft, a xenograft, an alloplast or a combination of these materials.
The rate of post-operative infection after a sinus lift procedure reaches 7%. An evidence based approach for antibiotic prophylaxis for this procedure does not exist. The standard of care is based on clinical experience and protocols for placing dental implants in the jaws bone.
The current protocols include broad spectrum antibiotics aimed at oral bacteria and main pathogens in acute bacterial sinusitis (Streptoccocus pneumoniae, Moraxella catarrhalis, Haemophilus influenzae): amoxicillin+clavulanic acid or clindamycin / clarithromycin+metronidazole for patients with penicillin allergy. According to the common protocol, the antibiotics are given one day prior to surgery or at the day of surgery (one hour before the first cut) and are continued for seven days post-operatively. This practice contradicts the current recommendation for a shortened postoperative course of antimicrobials for less than 24 hours (10). No evidence suggests that prescribing antibiotics beyond 24 hours lowers the rate of SSI. On the other hand, a prolonged prophylactic regimen elevates the risk of Clostridium difficile infection and contributes to antibiotic resistance.
Lindenboom and Van den Akker have demonstrated in 2003 that not administrating prophylactic antibiotics at all prior to bone augmentation elevates the rate of SSI significantly in comparison with a patient who receives antibiotics. On the other hand, our clinical experience shows that short term prophylactic antibiotics (up to 3 days post-operatively) in sinus augmentation surgery and other bone augmentations in the oral cavity do not elevate the risk of SSI. The need to prescribe antibiotics for more than 24 hours post-operatively was never evaluated in a clinical trial.
In the current trial we will test the hypothesis that a short prophylactic regimen does not differ from a prolonged one. On the contrary, we hypothesize that the adverse effects rate will be lower in patients that will receive antibiotics for a short period.
Aim of the study
This is a prospective randomized non-blinded trial which compares a short prophylactic regimen (till on day post-operatively) with a long prophylactic regimen (till seven days post-operatively as acceptable currently) in patients that undergo sinus augmentation surgery.
Study hypothesis: both groups will display similar rates of SSIs.
Materials and methods
The participants will be recruited from patients in Tel-Aviv Medical Center dental clinic that are in need for a unilateral or bilateral sinus augmentation surgery.
The recruited patients will meet the chief investigator for a thorough explanation on the trial, emphasizing the fact that the surgery itself is not the essence of this trial. After signing an informed consent for participating in the trial, the patients will be randomly split into two groups. The recruited patients will receive a prescription for antibiotics and how to take them: amoxicillin-clavulanate 875mg twice a day starting at the morning of surgery. Patient with penicillin allergy will receive a loading dose of clindamycin 300mg, followed by 150mg every 6 hours. The duration of treatment (one day or seven days post-operatively) will be determined according to the group attribution.
The sinus augmentation surgeries will be performed by the attending surgeons at the Oral and Maxillofacial department, according to a unified protocol: a pre-op chlorhexidine 2% rinse, local anesthesia with Lidocaine 2% with adrenalin 1:100000, elevation of a mucoperiosteal flap to expose the lateral wall of the sinus, performing an access window in the bony wall and lifting the sinus membrane, augmentation of the cavity using a xenogeneic and /or allogeneic bone graft substitute and a collagen membrane, placement of dental implants if feasible and suturing of the flap.
Augmenting the cavity with different materials reflects the common practice and based on the fact that these differences do not alter the rate of post-operative complications or dental implants failure in sinus augmentation sites.
Further treatment with dexamethasone, decongestants and pain medications will be administered according to current protocols and are subject to the surgeon's judgment in order to reflect the common practice.
The patients will be evaluated at the following appointed times until the placement/exposure of the dental implants: one week, two weeks, one month, two months, six months. These dates are part of the standard of care as a follow-up after sinus augmentation surgery.
Patients will be withdrawn from the study if they will not attend the follow-up appointments.
The use of antibiotics as prophylaxis for surgical site infection (SSI) is well based in most fields of surgery. The use of prophylactic antibiotics can reduce the rate of post-surgical infections substantially. Nonetheless, overuse of these drugs is likely to expose patients to adverse effects, increase the rate of microbial drug resistance and lead to unnecessary expenses.
In the field of dentistry there are recommendations for prevention of infective endocarditis. The use of antibiotics for SSI in the field of oral and maxillofacial surgery is not well established, with inconsistent and even contradictory recommendations.
Sinus floor lift and augmentation is a common surgical procedure in modern dentistry. It aims to increase the amount of bone in the posterior maxilla, in the area of the premolar and molar teeth, prior to placement of dental implants. The procedure is performed in a per-oral approach; a mucoperiosteal flap is elevated, the lateral boney wall of the sinus is exposed and a window is cut with a surgical bur. The Schneiderian membrane (sinus periost) is separated and lifted from the bone and a bone graft material is placed into the newly created space. The graft material used can be an autograft, an allograft, a xenograft, an alloplast or a combination of these materials.
The rate of post-operative infection after a sinus lift procedure reaches 7%. An evidence based approach for antibiotic prophylaxis for this procedure does not exist. The standard of care is based on clinical experience and protocols for placing dental implants in the jaws bone.
The current protocols include broad spectrum antibiotics aimed at oral bacteria and main pathogens in acute bacterial sinusitis (Streptoccocus pneumoniae, Moraxella catarrhalis, Haemophilus influenzae): amoxicillin+clavulanic acid or clindamycin / clarithromycin+metronidazole for patients with penicillin allergy. According to the common protocol, the antibiotics are given one day prior to surgery or at the day of surgery (one hour before the first cut) and are continued for seven days post-operatively. This practice contradicts the current recommendation for a shortened postoperative course of antimicrobials for less than 24 hours (10). No evidence suggests that prescribing antibiotics beyond 24 hours lowers the rate of SSI. On the other hand, a prolonged prophylactic regimen elevates the risk of Clostridium difficile infection and contributes to antibiotic resistance.
Lindenboom and Van den Akker have demonstrated in 2003 that not administrating prophylactic antibiotics at all prior to bone augmentation elevates the rate of SSI significantly in comparison with a patient who receives antibiotics. On the other hand, our clinical experience shows that short term prophylactic antibiotics (up to 3 days post-operatively) in sinus augmentation surgery and other bone augmentations in the oral cavity do not elevate the risk of SSI. The need to prescribe antibiotics for more than 24 hours post-operatively was never evaluated in a clinical trial.
In the current trial we will test the hypothesis that a short prophylactic regimen does not differ from a prolonged one. On the contrary, we hypothesize that the adverse effects rate will be lower in patients that will receive antibiotics for a short period.
Aim of the study
This is a prospective randomized non-blinded trial which compares a short prophylactic regimen (till on day post-operatively) with a long prophylactic regimen (till seven days post-operatively as acceptable currently) in patients that undergo sinus augmentation surgery.
Study hypothesis: both groups will display similar rates of SSIs.
Materials and methods
The participants will be recruited from patients in Tel-Aviv Medical Center dental clinic that are in need for a unilateral or bilateral sinus augmentation surgery.
The recruited patients will meet the chief investigator for a thorough explanation on the trial, emphasizing the fact that the surgery itself is not the essence of this trial. After signing an informed consent for participating in the trial, the patients will be randomly split into two groups. The recruited patients will receive a prescription for antibiotics and how to take them: amoxicillin-clavulanate 875mg twice a day starting at the morning of surgery. Patient with penicillin allergy will receive a loading dose of clindamycin 300mg, followed by 150mg every 6 hours. The duration of treatment (one day or seven days post-operatively) will be determined according to the group attribution.
The sinus augmentation surgeries will be performed by the attending surgeons at the Oral and Maxillofacial department, according to a unified protocol: a pre-op chlorhexidine 2% rinse, local anesthesia with Lidocaine 2% with adrenalin 1:100000, elevation of a mucoperiosteal flap to expose the lateral wall of the sinus, performing an access window in the bony wall and lifting the sinus membrane, augmentation of the cavity using a xenogeneic and /or allogeneic bone graft substitute and a collagen membrane, placement of dental implants if feasible and suturing of the flap.
Augmenting the cavity with different materials reflects the common practice and based on the fact that these differences do not alter the rate of post-operative complications or dental implants failure in sinus augmentation sites.
Further treatment with dexamethasone, decongestants and pain medications will be administered according to current protocols and are subject to the surgeon's judgment in order to reflect the common practice.
The patients will be evaluated at the following appointed times until the placement/exposure of the dental implants: one week, two weeks, one month, two months, six months. These dates are part of the standard of care as a follow-up after sinus augmentation surgery.
Patients will be withdrawn from the study if they will not attend the follow-up appointments.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Maxillofacial Surgery
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Short treatment
Short course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses.
Group Type
EXPERIMENTAL
Amoxicillin-Potassium Clavulanate Combination
Intervention Type
DRUG
Short course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses.
Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7.
Long treatment
Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7.
Group Type
ACTIVE_COMPARATOR
Amoxicillin-Potassium Clavulanate Combination
Intervention Type
DRUG
Short course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses.
Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amoxicillin-Potassium Clavulanate Combination
Short course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses.
Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7.
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Adult patient (18 years of age or older) that requires a unilateral or bilateral sinus augmentation surgery.
2. Weight \<150 kg.
2. Weight \<150 kg.
Exclusion Criteria
1. Need for prophylactic antibiotics for infective endocarditis.
2. Chronic antibiotics therapy.
3. Special populations: pregnant women, minors and legally incompetent patients.
4. Patients receiving anticoagulants.
5. Non-balanced diabetes mellitus.
6. Immune-suppression: corticosteroids treatment equivalent to 15mg prednisone for at least 14 days in the past month; chemotherapy, TNF inhibitor or drugs that suppress T-cell activity during the past 90 days; HIV infection.
7. Pathology of the maxillary sinus.
8. History of chronic sinusitis.
9. Patients that underwent a Caldwell-Luc procedure.
10. Patients with residual teeth roots at the planned surgical site.
11. A known state of carriage of Methicillin resistant Staphylococcus aureus or Clostridium difficile in the past year.
2. Chronic antibiotics therapy.
3. Special populations: pregnant women, minors and legally incompetent patients.
4. Patients receiving anticoagulants.
5. Non-balanced diabetes mellitus.
6. Immune-suppression: corticosteroids treatment equivalent to 15mg prednisone for at least 14 days in the past month; chemotherapy, TNF inhibitor or drugs that suppress T-cell activity during the past 90 days; HIV infection.
7. Pathology of the maxillary sinus.
8. History of chronic sinusitis.
9. Patients that underwent a Caldwell-Luc procedure.
10. Patients with residual teeth roots at the planned surgical site.
11. A known state of carriage of Methicillin resistant Staphylococcus aureus or Clostridium difficile in the past year.
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tel-Aviv Sourasky Medical Center
OTHER_GOV
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
michal roll
Head of Resaerch and Development Department
Responsibility Role
PRINCIPAL_INVESTIGATOR
References
Explore related publications, articles, or registry entries linked to this study.
Young PY, Khadaroo RG. Surgical site infections. Surg Clin North Am. 2014 Dec;94(6):1245-64. doi: 10.1016/j.suc.2014.08.008. Epub 2014 Oct 3.
Reference Type
BACKGROUND
Wilson W, Taubert KA, Gewitz M, Lockhart PB, Baddour LM, Levison M, Bolger A, Cabell CH, Takahashi M, Baltimore RS, Newburger JW, Strom BL, Tani LY, Gerber M, Bonow RO, Pallasch T, Shulman ST, Rowley AH, Burns JC, Ferrieri P, Gardner T, Goff D, Durack DT; American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee; American Heart Association Council on Cardiovascular Disease in the Young; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Cardiovascular Surgery and Anesthesia; Quality of Care and Outcomes Research Interdisciplinary Working Group. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2007 Oct 9;116(15):1736-54. doi: 10.1161/CIRCULATIONAHA.106.183095. Epub 2007 Apr 19.
Reference Type
BACKGROUND
Anitua E, Aguirre JJ, Gorosabel A, Barrio P, Errazquin JM, Roman P, Pla R, Carrete J, de Petro J, Orive G. A multicentre placebo-controlled randomised clinical trial of antibiotic prophylaxis for placement of single dental implants. Eur J Oral Implantol. 2009 Winter;2(4):283-92.
Reference Type
BACKGROUND
Mazzocchi A, Passi L, Moretti R. Retrospective analysis of 736 implants inserted without antibiotic therapy. J Oral Maxillofac Surg. 2007 Nov;65(11):2321-3. doi: 10.1016/j.joms.2007.06.620.
Reference Type
BACKGROUND
Laskin DM, Dent CD, Morris HF, Ochi S, Olson JW. The influence of preoperative antibiotics on success of endosseous implants at 36 months. Ann Periodontol. 2000 Dec;5(1):166-74. doi: 10.1902/annals.2000.5.1.166.
Reference Type
BACKGROUND
Choukroun J, Simonpieri A, Del Corso M, Mazor Z, Sammartino G, Dohan Ehrenfest DM. Controlling systematic perioperative anaerobic contamination during sinus-lift procedures by using metronidazole: an innovative approach. Implant Dent. 2008 Sep;17(3):257-70. doi: 10.1097/ID.0b013e318181349a.
Reference Type
BACKGROUND
Testori T, Drago L, Wallace SS, Capelli M, Galli F, Zuffetti F, Parenti A, Deflorian M, Fumagalli L, Weinstein RL, Maiorana C, Di Stefano D, Valentini P, Gianni AB, Chiapasco M, Vinci R, Pignataro L, Mantovani M, Torretta S, Pipolo C, Felisati G, Padoan G, Castelnuovo P, Mattina R, Del Fabbro M. Prevention and treatment of postoperative infections after sinus elevation surgery: clinical consensus and recommendations. Int J Dent. 2012;2012:365809. doi: 10.1155/2012/365809. Epub 2012 Aug 9.
Reference Type
BACKGROUND
Esposito M, Cannizzaro G, Bozzoli P, Checchi L, Ferri V, Landriani S, Leone M, Todisco M, Torchio C, Testori T, Galli F, Felice P. Effectiveness of prophylactic antibiotics at placement of dental implants: a pragmatic multicentre placebo-controlled randomised clinical trial. Eur J Oral Implantol. 2010 Summer;3(2):135-43.
Reference Type
BACKGROUND
Esposito M, Grusovin MG, Loli V, Coulthard P, Worthington HV. Does antibiotic prophylaxis at implant placement decrease early implant failures? A Cochrane systematic review. Eur J Oral Implantol. 2010 Summer;3(2):101-10.
Reference Type
BACKGROUND
Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available.
Reference Type
BACKGROUND
Cohen SH, Gerding DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, Wilcox MH; Society for Healthcare Epidemiology of America; Infectious Diseases Society of America. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the society for healthcare epidemiology of America (SHEA) and the infectious diseases society of America (IDSA). Infect Control Hosp Epidemiol. 2010 May;31(5):431-55. doi: 10.1086/651706.
Reference Type
BACKGROUND
Lindeboom JA, van den Akker HP. A prospective placebo-controlled double-blind trial of antibiotic prophylaxis in intraoral bone grafting procedures: a pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Dec;96(6):669-72. doi: 10.1016/j.tripleo.2003.08.026.
Reference Type
BACKGROUND
Herzberg R, Dolev E, Schwartz-Arad D. Implant marginal bone loss in maxillary sinus grafts. Int J Oral Maxillofac Implants. 2006 Jan-Feb;21(1):103-10.
Reference Type
BACKGROUND
Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TASMC-15-RB-0059-CTIL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis
NCT00245440
TERMINATED
PHASE4
A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.
NCT00236522
COMPLETED
PHASE3
Levofloxacin in Bacterial Rhinosinussitis
NCT02712502
COMPLETED
Zmax Compared to Augmentin in Sinusitis
NCT00367120
COMPLETED
PHASE4
AUGMENTIN 1gm In Skin And Soft Tissue Infection
NCT00343135
COMPLETED
PHASE4
Efficacy of Oral vs IV Antibiotics in the Treatment of Orofacial Osteomyelitis
NCT05867654
NOT_YET_RECRUITING
PHASE4
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
NCT02340000
COMPLETED
PHASE4
Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
NCT00493038
TERMINATED
PHASE4
Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life
NCT00147914
COMPLETED
PHASE4
Randomized Trial of Amoxicillin Versus Placebo for (Fast Breathing) Pneumonia
NCT02372461
COMPLETED
NA
Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
NCT00644553
COMPLETED
PHASE3
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
NCT00643409
COMPLETED
PHASE3
Retapamulin Ointment in Healthy Adults Nasally Colonized With Staphylococcus Aureus
NCT00539994
COMPLETED
PHASE2
Amoxicillin Susceptibility of Oral Streptococci After a 3-Day or a 7-Day Amoxicillin Therapy
NCT00764062
TERMINATED
PHASE4
Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia
NCT02813694
COMPLETED
PHASE3
Treatment of Patients With Acute Sinusitis
NCT00930488
COMPLETED
Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia
NCT02559310
COMPLETED
PHASE3
Assessing the Necessity of Prescribing Antibiotics (Clavulin or Clindamycin Versus Placebo) Post-peritonsillar Abscess Drainage
NCT01715610
WITHDRAWN
NA
Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia
NCT00035347
COMPLETED
PHASE4
Effect of Minocycline & Amoxicillin on Antibiotic Resistant Bacteria and Indigenous Microbiotas
NCT02030912
COMPLETED
PHASE4
Amoxicillin-clavulanate Alone or in Combination With Ciprofloxacin in Low-Risk Febrile Neutropenic Adult Patients: A Prospective, Double-blind, Randomized, Non-Inferiority Multicenter, Phase III Clinical Trial.
NCT04698057
WITHDRAWN
PHASE3
Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects
NCT01026545
COMPLETED
PHASE1