Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-04-14 @ 7:32 AM
Study NCT ID:
NCT03178292
Status:
UNKNOWN
Last Update Posted:
2017-06-06
First Post:
2017-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064704', 'term': 'Levofloxacin'}], 'ancestors': [{'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-05', 'studyFirstSubmitDate': '2017-05-28', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper urinary tract infection and systemic inflammatory response syndrome (SIRS) after PCNL by Criteria for SIRS established by the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference', 'timeFrame': '1 year', 'description': 'SIRS if patient has Two or more of the 4 SIRS criteria'}], 'secondaryOutcomes': [{'measure': 'difference between culture and sensitivity of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone.', 'timeFrame': '1 year', 'description': 'Preoperative urine (MSU),intraoperative renal pelvic urine and extracted stone culture and sensitivity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Percutaneous Nephrolithotomy', 'Infection', 'Sepsis', 'Antibiotics']}, 'descriptionModule': {'briefSummary': 'To evaluate whether 5 days of levofloxacin before percutaneous nephrolithotomy (PCNL) in reducing upper urinary tract infection and urosepsis after PCNL.', 'detailedDescription': 'Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure for removal of large volume upper urinary tract stones. Although PCNL is effective and yielding high stone-free rates, complications rates range from 18.30% to 83% with sepsis has been reported in 0.3% to 7.6% of cases result in the most common cause of perioperative mortality in PCNL patients.\n\nUrosepsis after PNL is an important and potentially catastrophic complication. The overall incidence of fever (25%), bacteremia (23%), endotoxemia (34%) and septicemic shock occurs in 0.3%-2.5% of patients. Urosepsis and shock result from the intravasation of bacteria or endotoxins into bloodstream, which in turn increases with prolonged surgery, degree of hydronephrosis, bacterial load in the renal pelvis, and presence of infected stones.\n\nCharton et al., concluded that without antibiotic prophylaxis 35% of patient suffered urinary tract infection a post-PCNL, although preoperative urine showing no growth. In a prospective but nonrandomized assessment of PCNL patients receiving oral ciprofloxacin, intravenous ciprofloxacin, or no antimicrobial treatment found postoperative urinary tract infection to occur in 17%, 0%, and 40% of patients, respectively. Mariappan et al., stated that midstream urine (MSU) culture does not represent upper tract infection in patients with obstructing stones. Also, stone and pelvic urine cultures are better predictors of upper tract infection and urosepsis in such cases.\n\nAntibiotic prophylaxis has been recommended (Level of evidence: IIb, III) for patients subjected to PCNL to avert these infectious complications, as profiled in an American Urological Association (AUA) Best Practice Policy Statement. They also recommend antibiotic prophylaxis before shock wave lithotripsy and ureteroscopy with high level (Level of evidence: Ia and Ib, respectively) due to presence of meta-analysis and large randomised controlled trial.\n\nThe optimal timing, dosing, and duration of a prophylactic antibiotic regimen for PCNL procedures has also been a point of discussion. The AUA best practice policy statement currently recommends that a one-time dose on the day of the procedure is sufficient. The EAU guidelines are less definitive in concluding that a short course is adequate but that the "length of time is to be determined." Mariappan and colleagues in a prospective non-randomised trial found that 52 patients who had dilated collecting systems, stone burden greater than 2 cm, and no confounding factors predisposing to UTIs who received a 1-week course of ciprofloxacin before PCNL had a 3-fold lower risk of postoperative UTI and SIRS than 46 patients who received standard perioperative antibiotics on the day of surgery.\n\nBag and colleagues prospectively randomized 101 patients with greater than 2.5-cm kidney stones and/or hydronephrosis with sterile preoperative urine cultures to a 7-day course of nitrofurantoin versus no antibiotics before PCNL and found a statistically significant lower rate of postoperative SIRS (19% vs 49%), endotoxemia (18% vs 42%), positive result on kidney urine culture (0% vs 10%), and positive result on stone culture (8% vs 30%) in the arm receiving nitrofurantoin.\n\nAlthough these two small series support a week of preoperative antibiotics before PCNL, larger, prospective, randomized studies are needed to better elucidate the risks and benefits of empiric antibiotics'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stones ≥ 2.5 cm and/or hydronephrosis\n* Sterile mid urine stream\n\nExclusion Criteria:\n\n* Patients with a stent, nephrostomy tube or indwelling catheter\n* Uncontrolled Diabetes mellitus\n* Renal failure\n* Fever before surgery\n* Concomitant bladder stone or tumour\n* Patients with active UTI\n* Contralateral renal/ureteric stone'}, 'identificationModule': {'nctId': 'NCT03178292', 'briefTitle': 'Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy (PCNL)', 'orgStudyIdInfo': {'id': 'Ab-PCNL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levofloxacin', 'description': 'Levofloxacin 500 mg daily for 5 days', 'interventionNames': ['Drug: Levofloxacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tab daily for 5 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Levofloxacin', 'type': 'DRUG', 'otherNames': ['Levofloxacin 500Mg'], 'description': 'Levofloxacin 500Mg daily for 5 days', 'armGroupLabels': ['Levofloxacin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['placebo Oral Tablet'], 'description': 'Placebo Oral Tablet daily for 5 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'country': 'Egypt', 'contacts': [{'name': 'Abdelwahab R. Hashem, Msc', 'role': 'CONTACT', 'email': 'abdelwahab_hashem@yahoo.com', 'phone': '01069678979', 'phoneExt': '002'}], 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Abdelwahab R. Hashem, Msc', 'role': 'CONTACT', 'email': 'abdelwahab_hashem@yahoo.com', 'phone': '01069678979', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Ahmed Shoma, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology and Nephrology center'}, {'name': 'Nasr Eltabey, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Urology and Nephrology center'}, {'name': 'Mahmoud Laimon, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology and Nephrology center'}, {'name': 'Muhamad Abdullateef, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology and Nephrology center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Yes meta-analyses by contact the Prof. Ahmed Shoma, MD, Phd (Study Chair)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator', 'investigatorFullName': 'Abdelwahab Hashem', 'investigatorAffiliation': 'Mansoura University'}}}}