anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sibofimloc
Trial phase: Phase 2
SMILES: [H][C@]1(C#Cc2ccc3c(c2)C2(CCN(C(C)=O)CC2)c2cc(C#C[C@@]4([H])O[C@H](CO)[C@@H](O)[C@H](O)[C@@H]4O)ccc2-3)O[C@H](CO)[C@@H](O)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
Eligibility criteria:
Inclusion Criteria:

Must have a documented diagnosis of CD confirmed by endoscopic biopsy before resection or by tissue obtained at resection.
Planned to undergo a laparoscopic ileocecal resection with primary anastomosis within 72 hours before randomization Day 1. Confirmation that no active disease has been left behind after resection will be based on surgeon's documentation in the operative report.
With postoperative discontinuation of all concomitant medications specifically related to the treatment of CD. This includes anti-tumor necrosis factor-alpha (TNF-α) and anti-integrin therapy, anti- interleukin (IL) 12/23, thiopurines and other immunomodulators, steroids, 5-minosalicylates, and prophylactic use of antibiotics for the prevention of postoperative recurrence such as metronidazole.
Has resumed oral intake and is capable of swallowing tablets within 72 hours after surgery.

Exclusion Criteria:

Has active perianal CD.
Has had >3 previous surgical procedures for CD.
Has macroscopically active CD that was not resected at the time of surgery as documented in the surgeon's operative report.
With small bowel resection that exceeds 100 centimeter (cm) or a participant who is considered at risk of short bowel syndrome by the surgeon or investigator.
Has active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following: history of tuberculosis, OR positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR a tuberculin skin test reaction ≥10 millimeter (mm) (≥5 mm in participants receiving the equivalent of >15 milligram per day (mg/day) prednisone).
Has chronic hepatitis B (hepatitis B surface antigen positive, or positive for both hepatitis B surface antibody and hepatitis B core antibody but negative for hepatitis B surface antigen) or hepatitis C infection (evident by viral replication by polymerase chain reaction) within 30 days of randomization.
Intervention: Estradiol
Trial phase: Phase 4
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Estrogen vaginal cream: Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.
Eligibility criteria:
Inclusion Criteria:

Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal will be defined as: amenorrhea for a year or 3 months after surgical bilateral salpingo-oophorectomy
Is a new pessary user, or has not had a pessary for a year

Exclusion Criteria:

Pregnancy
Persistent Bacterial Vaginosis infection in the first two clinic encounters
Currently on hormone replacement therapy
Previously on hormone replacement therapy in the past 6 months
Currently on antibiotics
Patients with existing vaginal erosions/ulcerations
Intervention: Sugammadex
Trial phase: Phase 2
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration

Sugammadex Injection 2mg/kg: Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration
Eligibility criteria:
Inclusion Criteria: All of below

Pediatric patients undergoing surgery under general anesthesia with requirement of early reversal of neuromuscular blockade
Aged between 2 and 17
American Society of Anesthesiologists Physical Status Classification 1 and 2

Exclusion Criteria: Any of below

One or more legal guardian declines to enroll in the study
History of hypersensitivity to any anesthetic agents including rocuronium
Presence of underlying cardiovascular or genitourinary disease
Under usage of neuromuscular blocking agents before surgery
Under usage of drugs influencing the effect of neuromuscular blocking agents
History of malignant hyperthermia
Anticipation of massive hemorrhage during surgery
Intervention: Sugammadex
Trial phase: Phase 2
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration

Sugammadex Injection 4mg/kg: Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration
Eligibility criteria:
Inclusion Criteria: All of below

Pediatric patients undergoing surgery under general anesthesia with requirement of early reversal of neuromuscular blockade
Aged between 2 and 17
American Society of Anesthesiologists Physical Status Classification 1 and 2

Exclusion Criteria: Any of below

One or more legal guardian declines to enroll in the study
History of hypersensitivity to any anesthetic agents including rocuronium
Presence of underlying cardiovascular or genitourinary disease
Under usage of neuromuscular blocking agents before surgery
Under usage of drugs influencing the effect of neuromuscular blocking agents
History of malignant hyperthermia
Anticipation of massive hemorrhage during surgery
Intervention: Sugammadex
Trial phase: Phase 2
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 40
Group description: Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration

Sugammadex Injection 8mg/kg: Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration
Eligibility criteria:
Inclusion Criteria: All of below

Pediatric patients undergoing surgery under general anesthesia with requirement of early reversal of neuromuscular blockade
Aged between 2 and 17
American Society of Anesthesiologists Physical Status Classification 1 and 2

Exclusion Criteria: Any of below

One or more legal guardian declines to enroll in the study
History of hypersensitivity to any anesthetic agents including rocuronium
Presence of underlying cardiovascular or genitourinary disease
Under usage of neuromuscular blocking agents before surgery
Under usage of drugs influencing the effect of neuromuscular blocking agents
History of malignant hyperthermia
Anticipation of massive hemorrhage during surgery
Intervention: Etrasimod
Trial phase: Phase 3
ATC code: L04AE05
SMILES: O=C(O)C[C@H]1CCc2c1[nH]c1ccc(OCc3ccc(C4CCCC4)c(C(F)(F)F)c3)cc21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 289
Group description: Etrasimod 2 mg was administered orally once daily for up to 52 weeks.
Eligibility criteria:
Inclusion criteria:

Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
Active UC confirmed by endoscopy

Exclusion criteria:

Severe extensive colitis
Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
Intervention: SODIUM CHLORIDE
Trial phase: Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 124
Group description: Normal saline is to be placed into the dissected retromuscular space AFTER placement and fixation of mesh. This should fill the cavity completely to the level of the skin. Irrigant is to be left to stand for a total of three minutes and then evacuated. Additional irrigation with saline PRIOR to the randomization is permitted at the surgeons' discretion for hemostasis with no requirement for duration. Additional saline irrigation of the subcutaneous space after fascia closure should be performed prior to skin closure.

Normal saline: Comparison of saline solution rinse vs antibiotic rinse
Eligibility criteria:
Inclusion Criteria:

Age >18 y/o.
Elective, open ventral hernia repair in a retromuscular fashion, with or without TAR.
Clean, clean-contaminated, or contaminated wounds.

Exclusion Criteria:

Age <18 y/o.
Pregnancy.
Emergency hernia repair.
Laparoscopic, robotic, or hybrid approach.
Dirty wounds.
Use of biologic or absorbable synthetic mesh.
Onlay, intraperitoneal or preperitoneal mesh placement.
Intervention: CID 163285897
Trial phase: Phase 3
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Participants received 5 mg of Tirzepatide as subcutaneous injection, once weekly.
Eligibility criteria:
Inclusion Criteria:

Have been diagnosed with type 2 diabetes mellitus (T2DM).
Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
Have HbA1c between ≥7.0% and ≤9.5%.
Be of stable weight (± 5%) for at least 3 months before screening.
Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

Have type 1 diabetes mellitus.
Have had chronic or acute pancreatitis any time prior to study entry.
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
Have an estimated glomerular filtration rate <30 mL/minute/1.73 m².
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Intervention: CID 163285897
Trial phase: Phase 3
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Participants received 10 mg of Tirzepatide as subcutaneous injection, once weekly.
Eligibility criteria:
Inclusion Criteria:

Have been diagnosed with type 2 diabetes mellitus (T2DM).
Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
Have HbA1c between ≥7.0% and ≤9.5%.
Be of stable weight (± 5%) for at least 3 months before screening.
Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

Have type 1 diabetes mellitus.
Have had chronic or acute pancreatitis any time prior to study entry.
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
Have an estimated glomerular filtration rate <30 mL/minute/1.73 m².
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Intervention: CID 163285897
Trial phase: Phase 3
ATC code: A10BX16
SMILES: CCC(C)C(NC(=O)C(CC(C)C)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)C(CCC(N)=O)NC(=O)C(C)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(C)(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(N)Cc1ccc(O)cc1)C(C)O)C(C)O)C(C)CC)C(C)CC)C(C)C)C(=O)NC(C)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Participants received 15 mg of Tirzepatide as subcutaneous injection, once weekly.
Eligibility criteria:
Inclusion Criteria:

Have been diagnosed with type 2 diabetes mellitus (T2DM).
Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
Have HbA1c between ≥7.0% and ≤9.5%.
Be of stable weight (± 5%) for at least 3 months before screening.
Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

Have type 1 diabetes mellitus.
Have had chronic or acute pancreatitis any time prior to study entry.
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
Have an estimated glomerular filtration rate <30 mL/minute/1.73 m².
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
Intervention: BALOXAVIR MARBOXIL
Trial phase: Not Applicable
ATC code: J05AX25
SMILES: [H][C@@]12COCCN1C(=O)c1c(OCOC(=O)OC)c(=O)ccn1N2[C@@H]1c2ccccc2SCc2c1ccc(F)c2F
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Administered orally on Day 1
Eligibility criteria:
Inclusion Criteria:

Chinese participants must have Chinese parents and grandparents, all of whom were born in China.
Healthy status as defined by absence of evidence of any active or chronic disease
Participants whose body weight is ≥50 to <80 kg and body mass index is ≥18.5 to <26 kg/m2

Exclusion Criteria:

Participants with a history of stomach, vagus nerve, or intestinal surgery (except for appendectomy)
Participants who have a history of allergic symptoms including food allergy (Note: Non-active allergic rhinitis will be allowed)
Participants who require chronic drug therapy or those who have used drugs within 3 days prior to screening or within 14 days prior to Day -1
Participants who have used alcohol-containing, caffeine-containing, grapefruit containing, or St. John's wort-containing products within 72 hours prior to Day -1
Participants who have used tobacco- or nicotine-containing products within 24 weeks prior to screening
Participants who have donated > 400 mL of blood within 12 weeks or > 200 mL of blood within 4 weeks prior to screening, or have donated any amount of blood between screening and Day -1
Intervention: Kovacaine
Trial phase: Phase 2
SMILES: CCCCNc1ccc(C(=O)OCCN(C)C)cc1.Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1.Cl.Cl
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth

Kovanaze Nasal Spray: Intra-nasal local anesthetic
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists Class I or II
Preoperative heart rate of 55 to 100 beats per minute
Maximum blood pressure reading of 166/100 mmHg
Treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia

Additional Pediatric Inclusion Criteria:

Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth

Additional Endodontic Inclusion Criteria:

Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth

Additional General Practice Inclusion Criteria:

Adults who require restorations in the maxillary teeth that would need local anesthesia

Exclusion Criteria:

Inadequately controlled thyroid disease
Five or more nosebleeds in the past month
Known allergy to any study drug or para-aminobenzoic acid
History of methemoglobinemia
Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);
Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.
Intervention: TNP-2092
Trial phase: Phase 2
SMILES: CO[C@H]1C=CO[C@@]2(C)Oc3c(C)c(O)c4c(O)c(c(/C=N/N5CCC(N(C)C6([C@@H]7CCN(c8c(F)cn9c(=O)c(C(=O)O)cc(C%10CC%10)c9c8C)C7)CC6)CC5)c(O)c4c3C2=O)NC(=O)C(C)=C/C=C\[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@H](C)[C@H](OC(C)=O)[C@H]1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 78
Group description: TNP-2092 300 mg intravenous every 12 hours

TNP-2092: TNP-2092 100mg/vial
Eligibility criteria:
Inclusion Criteria:

Subjects may be included in the study if they meet all of the following inclusion criteria:

Males or females, 18 years of age or older;
ABSSSI suspected or confirmed to be caused by gram-positive pathogens, including:
Cellulitis/erysipelas;
Wound infection;
Major cutaneous abscess;
Lesion with a minimum surface area of 75 cm2;
Capable of giving signed informed consent.

Exclusion Criteria:

Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:

History or hypersensitivity or intolerability to any fluoroquinolone, rifamycin or glycopeptide classes;
ABSSSI suspected or confirmed to be caused by pathogens that are resistant to the glycopeptide class;
Prior administration of systemic antibacterial therapy within 96 hours before randomization;
ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobic organisms;
ABSSSI with suspected or confirmed infection caused by fungal, mycobacterial, parasitic, or viral pathogens;
Evidence of significant hepatic, hematologic, or immunologic disease;
History or evidence of severe renal disease.
Intervention: Vancomycin
Trial phase: Phase 2
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: vancomycin 1 g intravenous every 12 hours

Vancomycin: Vancomycin 1g/vial
Eligibility criteria:
Inclusion Criteria:

Subjects may be included in the study if they meet all of the following inclusion criteria:

Males or females, 18 years of age or older;
ABSSSI suspected or confirmed to be caused by gram-positive pathogens, including:
Cellulitis/erysipelas;
Wound infection;
Major cutaneous abscess;
Lesion with a minimum surface area of 75 cm2;
Capable of giving signed informed consent.

Exclusion Criteria:

Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:

History or hypersensitivity or intolerability to any fluoroquinolone, rifamycin or glycopeptide classes;
ABSSSI suspected or confirmed to be caused by pathogens that are resistant to the glycopeptide class;
Prior administration of systemic antibacterial therapy within 96 hours before randomization;
ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobic organisms;
ABSSSI with suspected or confirmed infection caused by fungal, mycobacterial, parasitic, or viral pathogens;
Evidence of significant hepatic, hematologic, or immunologic disease;
History or evidence of severe renal disease.