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Surgery

The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

N/A
Recruiting
Led By Juan Sanabria, MD MSc FACS
Research Sponsored by Marshall University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for appendicitis that may be less invasive than surgery. Patients with appendicitis will be treated with antibiotics and, if they improve, will be discharged and monitored. If they do not improve, they will stay in the hospital for more treatment.

Eligible Conditions
  • Ruptured appendix

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 3 trial • 727 Patients • NCT02085408
98%
White blood cell decreased
96%
Platelet count decreased
94%
Neutrophil count decreased
91%
Anemia
73%
Aspartate aminotransferase increased
71%
Alanine aminotransferase increased
59%
Blood bilirubin increased
55%
Febrile neutropenia
46%
Alkaline phosphatase increased
34%
Hypomagnesemia
26%
Creatinine increased
23%
Lymphocyte count decreased
12%
Lung infection
12%
Hypermagnesemia
8%
Hypokalemia
8%
Sepsis
7%
Hypophosphatemia
6%
Dyspnea
6%
Rash maculo-papular
5%
Fatigue
5%
Hypoxia
5%
Infections and infestations - Other
5%
Hypotension
5%
Hypocalcemia
4%
Acute kidney injury
4%
Catheter related infection
4%
Hyponatremia
4%
Anorexia
4%
Diarrhea
3%
Hypertension
3%
Hyperglycemia
3%
Generalized muscle weakness
3%
Hypoalbuminemia
3%
Respiratory failure
3%
Urinary tract infection
2%
Atrial fibrillation
2%
Enterocolitis infectious
2%
Epistaxis
2%
Nausea
1%
Skin infection
1%
Soft tissue infection
1%
Multi-organ failure
1%
Confusion
1%
Acidosis
1%
Bone pain
1%
Pruritus
1%
Enterocolitis
1%
Cardiac disorders - Other, specify
1%
Non-cardiac chest pain
1%
Rectal hemorrhage
1%
Edema limbs
1%
Intracranial hemorrhage
1%
Investigations - Other, specify
1%
Heart failure
1%
Sinus tachycardia
1%
Supraventricular tachycardia
1%
Colitis
1%
Vomiting
1%
Upper respiratory infection
1%
Weight loss
1%
Pain in extremity
1%
Headache
1%
Hiccups
1%
Pulmonary edema
1%
Adult respiratory distress syndrome
1%
Left ventricular systolic dysfunction
1%
Sinusitis
1%
Blood and lymphatic disorders - Other
1%
Dehydration
1%
Tumor lysis syndrome
1%
Stroke
1%
Syncope
1%
Vasovagal reaction
1%
Abdominal pain
1%
Thromboembolic event
1%
Mucositis oral
1%
Lower gastrointestinal hemorrhage
1%
Typhlitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm B (Induction: Clofarabine)
Arm F (Maintenance: Decitabine)
Arm A (Induction: Daunorubicin + Cytarabine)
Arm C (Consolidation: Cytarabine)
Arm D (Consolidation: Clofarabine)
Arm E (Maintenance: Observation)
Arm G (Transplant)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Experimental pediatric group:Experimental Treatment1 Intervention
patients ≤17 yo with acute perforated appendicitis abscess and observation (n=25)
Group II: Experimental adult group:Experimental Treatment1 Intervention
Patients ≥18 yo with acute perforated appendicitis and observation (n=25)
Group III: Standard pediatric group:Active Control1 Intervention
patients ≤17 yo with acute perforated appendicitis and interval appendectomy (n=25)
Group IV: Standard adult group:Active Control1 Intervention
patients ≥18 yo with acute perforated appendicitis and interval appendectomy (n=25)

Find a Location

Who is running the clinical trial?

Marshall UniversityLead Sponsor
20 Previous Clinical Trials
3,830 Total Patients Enrolled
Juan Sanabria, MD MSc FACS5.01 ReviewsPrincipal Investigator - Marshall University School of Medicine
Marshall University
1 Previous Clinical Trials
159 Total Patients Enrolled

Media Library

Appendectomy (Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT04253899 — N/A
Ruptured appendix Research Study Groups: Standard pediatric group:, Experimental pediatric group:, Standard adult group:, Experimental adult group:
Ruptured appendix Clinical Trial 2023: Appendectomy Highlights & Side Effects. Trial Name: NCT04253899 — N/A
Appendectomy (Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04253899 — N/A
~17 spots leftby Jan 2026
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