Study of efficinency of drug treatment for non-complicated acute appendicitis in 7 to 18 years old children.

Clinical and economical efficiency and safety and inflammation parameter correlations study of concervative treatment of non-complicated acute appendicitis in 7 to 18 years old children.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001729-38-LV

Enrollment

120

Registered

2021-08-06

Start date

2021-07-02

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute non-complicated appendicitis in patients aged 7 to 18

Interventions

Trade Name: Ceftazidime Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Ceftazidime Other descriptive name: CEFTAZIDIME PENTAHYDRATE Trade Name: Ampicillin Pharmaceutical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age: 7-18 years Dg. Primary acute non-complicated appendicitis ALVORADO score = 7 Pain in right lower quadrant of abdomen Blood tests: C-reactive protein = 10 mg/L *If performed: *Il-6 = 39,2 pg/mL *Ultrasound - acute appendicitis signs Are the trial subjects under 18? yes Number of subjects for this age range: 120 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Positive pregnancy test Diffuse peritonitis Previous abdominal surgery Use of antibiotic drugs in previous 7 days Inflammatory bowel disease Immunosuppresive condition

Design outcomes

Primary

Measure	Time frame
Main Objective: To perform a complex clinical and economical study in children with acute appendicitis, provide new criteria for early diagnosis of acute non-complicated appendicitis and its conservative treatment, as well as evaluate cost-efficiency.;Secondary Objective: Not applicable;Primary end point(s): Full recovery. Initial treatment failure - appendectomy performed. 1-year recurrance free.;Timepoint(s) of evaluation of this end point: Day 1-3: in-patient treatment. Day 4-10: out-patient treatment. Follow-up on month 1 and month 12.	—

Measure

Time frame

Main Objective: To perform a complex clinical and economical study in children with acute appendicitis, provide new criteria for early diagnosis of acute non-complicated appendicitis and its conservative treatment, as well as evaluate cost-efficiency.;Secondary Objective: Not applicable;Primary end point(s): Full recovery. Initial treatment failure - appendectomy performed. 1-year recurrance free.;Timepoint(s) of evaluation of this end point: Day 1-3: in-patient treatment. Day 4-10: out-patient treatment. Follow-up on month 1 and month 12.

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in inflammation marker levels during hosital stay. Abdominal pain 1 year after treatment.;Timepoint(s) of evaluation of this end point: Days 1-3 - daily Follow-up on month 12.	—

Countries

Latvia

Contacts

Public ContactPediatric Surgery Department

Riga Stradins University

bkk@rsu.lv+37167622923

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026