Ongoing Clinical Trials for Appendicitis
This article provides information about 8 ongoing clinical trials investigating new treatment approaches for appendicitis. These trials are being conducted in Finland, France, Latvia, and the Netherlands, and are exploring antibiotic therapies, pain management, and post-surgical care strategies for both children and adults with acute appendicitis.
Clinical trial locations
- Finland
- Study Comparing Antibiotic Treatment with Placebo for Patients with Acute Appendicitis Using Ertapenem, Metronidazole, and Levofloxacin
- Study on Antibiotic Treatment for Uncomplicated Acute Appendicitis Using Levofloxacin, Ertapenem, and Moxifloxacin in Adult Patients
- Study on Moxifloxacin for Treating Uncomplicated Acute Appendicitis in Adults
- Study on the Effects of Moxifloxacin and Drug Combination for Patients with Acute Appendicitis
- France
- Latvia
- Netherlands
Study on Using Gentamicin and Clindamycin to Prevent Abscesses After Surgery for Complicated Appendicitis in Patients
This trial is investigating a new approach to prevent complications after surgery for complicated appendicitis. The study focuses on using an antibiotic wash during surgery to reduce the risk of developing an abscess, which is a collection of pus that can form after the appendix is removed.
Inclusion criteria: Participants must be at least 8 years old with a confirmed diagnosis of acute appendicitis undergoing laparoscopic appendectomy. During surgery, the condition must be confirmed as complicated. Both males and females can participate, and written consent is required.
Exclusion criteria: People with known allergies to gentamicin or clindamycin, those with a history of severe allergic reactions to medications, pregnant or breastfeeding women, and those with other serious health conditions that could interfere with the study are excluded. People unable to follow study procedures or participating in other clinical trials also cannot join.
Study focus: The main goal is to evaluate whether washing the abdominal cavity with gentamicin and clindamycin during surgery can reduce the risk of developing an intra-abdominal abscess by at least 50%. Participants will be monitored for 30 days after surgery to check for signs of abscess, and other aspects such as wound infections and overall recovery will be observed for up to 90 days.
Investigational drugs: The study uses gentamicin and clindamycin, both antibiotics applied directly to the abdominal area during surgery. These medications work by stopping bacterial protein synthesis to prevent infections and abscess formation.
Study Comparing Antibiotic Treatment with Placebo for Patients with Acute Appendicitis Using Ertapenem, Metronidazole, and Levofloxacin
This trial explores whether antibiotics alone can successfully treat uncomplicated acute appendicitis without surgery. The study compares antibiotic therapy with a placebo to determine if medications can resolve the inflammation without surgical intervention.
Inclusion criteria: Participants must be between 18 and 60 years old with a CT scan confirming uncomplicated acute appendicitis. Signed informed consent is required.
Exclusion criteria: People with complicated appendicitis, those younger than 3 years old, and vulnerable populations are excluded from participation.
Study focus: The primary goal is to determine whether antibiotic therapy can successfully treat uncomplicated acute appendicitis, allowing hospital discharge without surgery. The study tracks complications, hospital stay length, and quality of life over time, with follow-up evaluations at one, three, five, and ten years.
Investigational drugs: The trial uses ertapenem (given intravenously), metronidazole, and levofloxacin (both taken orally). These antibiotics work by killing or stopping the growth of bacteria causing the infection.
Study on Antibiotic Treatment for Uncomplicated Acute Appendicitis Using Levofloxacin, Ertapenem, and Moxifloxacin in Adult Patients
This study compares two different antibiotic approaches for treating uncomplicated acute appendicitis: oral antibiotics alone versus a combination of intravenous antibiotics followed by oral antibiotics.
Inclusion criteria: Adults aged 18 to 60 years with a CT scan confirming uncomplicated acute appendicitis are eligible. The CT scan must show an appendix larger than 6 millimeters with a thickened wall and surrounding swelling, without signs of complicated appendicitis.
Exclusion criteria: People with complicated appendicitis, those younger than 18 years, and vulnerable populations are not eligible.
Study focus: The trial aims to determine if oral antibiotic treatment alone is as effective as the combination approach. Success is defined as resolution of appendicitis without surgery and no recurrence within one year. The study also evaluates complications, hospital stay duration, pain levels, and quality of life.
Investigational drugs: The medications include levofloxacin, moxifloxacin, metronidazole (oral tablets), and ertapenem (intravenous infusion). These are antimicrobial agents used to treat bacterial infections.
Study on Moxifloxacin for Treating Uncomplicated Acute Appendicitis in Adults
This trial investigates whether antibiotics are necessary for treating uncomplicated acute appendicitis by comparing moxifloxacin with a placebo.
Inclusion criteria: Participants must be 18 to 60 years old with uncomplicated acute appendicitis confirmed by CT scan and must provide signed informed consent.
Exclusion criteria: People with complicated appendicitis, those younger than 3 years, and vulnerable populations cannot participate.
Study focus: The main goal is to determine whether antibiotic treatment with moxifloxacin can resolve appendicitis without surgery within 30 days. The study monitors complications, recurrence, hospital stay length, pain levels, and quality of life.
Investigational drugs: The study uses moxifloxacin, a 400 mg oral tablet taken once daily. The trial compares its effectiveness against a placebo to see if antibiotics can be safely omitted in treating this condition.
Study on Pain Management in Children Aged 7-18 with Acute Appendicitis Using Ketorolac Trometamol
This trial focuses on pain management in children with uncomplicated acute appendicitis who are receiving non-surgical treatment. The study examines how well ketorolac works in managing pain and other health factors.
Inclusion criteria: Children aged 7 to 18 years with a first-time diagnosis of uncomplicated acute appendicitis receiving non-surgical treatment can participate. Both boys and girls are eligible.
Exclusion criteria: Children with complicated appendicitis, those outside the age range, those unable to follow study procedures, those with other interfering medical conditions, current participation in another trial, allergies to study medications, and pregnant or breastfeeding participants are excluded.
Study focus: The study aims to develop a pain management plan based on how ketorolac affects pain levels and other clinical indicators over three days. Some participants may receive a placebo for comparison.
Investigational drugs: The trial uses ketorolac trometamol (30 mg/ml injection), along with antibiotics to reduce infection and pain relievers to manage discomfort during recovery.
Study on Post-Surgery Antibiotic Use in Patients with Complicated Acute Appendicitis: Evaluating Metronidazole, Ceftriaxone, and Ofloxacin Hydrochloride
This trial evaluates whether antibiotics are necessary after surgery for complicated acute appendicitis. The study examines the impact of not using post-operative antibiotics on infection rates at the surgical site.
Inclusion criteria: Participants must be 18 years or older with complicated acute appendicitis confirmed during laparoscopic appendectomy. The condition must include a perforated appendix, fecaliths outside the appendix, abscesses, or localized peritonitis. Signed informed consent is required.
Exclusion criteria: People with generalized peritonitis (widespread abdominal inflammation) and vulnerable populations cannot participate.
Study focus: The primary goal is to assess infection rates at the surgical site within 30 days when antibiotics are not used after surgery. The study also evaluates quality of life, antibiotic-free days, and the balance between antibiotic use and bacterial resistance.
Investigational drugs: The medications include metronidazole, ceftriaxone, and levofloxacin, administered through infusion. A placebo group is included for comparison.
Study on the Effectiveness and Safety of Amoxicillin, Clavulanic Acid, and Metronidazole for Treating Acute Appendicitis in Children Aged 7 to 18
This trial explores conservative (non-surgical) treatment for acute non-complicated appendicitis in children using antibiotic therapy. The study evaluates effectiveness, safety, and cost-effectiveness of this approach.
Inclusion criteria: Children aged 7 to 18 years with primary acute non-complicated appendicitis are eligible. They must have an ALVORADO score of 7 or higher, pain in the right lower abdomen, C-reactive protein of 10 mg/L or less, Il-6 level of 39.2 pg/mL or less (if tested), and ultrasound confirmation of acute appendicitis.
Exclusion criteria: Children outside the age range, those without acute non-complicated appendicitis, those with interfering medical conditions, inability to follow procedures, recent participation in other trials, pregnancy or breastfeeding, severe allergy history, and those taking medications affecting study results are excluded.
Study focus: The trial evaluates how well antibiotic treatment manages appendicitis without surgery over 10 days (3 days in-patient, 7 days out-patient), with follow-up at one month and one year to monitor long-term outcomes.
Investigational drugs: The medications include amoxicillin with clavulanic acid, metronidazole, ampicillin, and ceftazidime. These antibiotics fight infections, while ibuprofen and paracetamol manage pain and reduce fever.
Study on the Effects of Moxifloxacin and Drug Combination for Patients with Acute Appendicitis
This study investigates the causes of acute appendicitis and examines how different antibiotic treatments affect gut bacteria (microbiota). The trial includes both uncomplicated and complicated forms of the condition.
Inclusion criteria: Participants must be 18 to 60 years old with signed informed consent and a CT scan confirming either uncomplicated or complicated acute appendicitis (including conditions like appendicolith, perforation, abscess, or suspected tumor).
Exclusion criteria: People with other serious health conditions, inability to follow study procedures, allergies to study medications, current participation in another trial, recent surgery affecting results, pregnancy or breastfeeding, history of drug or alcohol abuse, mental health conditions affecting participation, known infections, or unstable chronic illness are excluded.
Study focus: The primary goal is to evaluate changes in gut microbiota and determine any correlation between these changes and the severity of appendicitis. The study also examines how hospital stay length influences gut bacteria.
Investigational drugs: The trial uses levofloxacin, moxifloxacin, metronidazole (oral), and ertapenem (intravenous). These antimicrobial treatments are evaluated for their impact on gut microbiota and antibiotic resistance development.
Summary
These eight clinical trials represent diverse approaches to managing appendicitis, from exploring non-surgical antibiotic treatments to optimizing post-operative care. A notable concentration of trials is taking place in Finland, with four studies examining various antibiotic regimens for uncomplicated acute appendicitis in adults. The Finnish trials are particularly focused on comparing oral versus intravenous antibiotic approaches and determining whether antibiotics can replace surgery entirely.
Several trials focus specifically on pediatric populations in Latvia, investigating both pain management and conservative treatment approaches for children aged 7 to 18 years. This highlights growing interest in avoiding surgery when possible in younger patients.
Common themes across the trials include the evaluation of fluoroquinolone antibiotics (such as moxifloxacin and levofloxacin), often combined with metronidazole. Multiple studies are investigating whether antibiotic therapy alone can effectively treat uncomplicated appendicitis without surgery, which could represent a significant shift in treatment approaches. Additionally, there is interest in understanding the impact of antibiotic treatments on gut microbiota and bacterial resistance.
The trials employ various study designs, including placebo-controlled studies and comparisons between different antibiotic regimens, with follow-up periods ranging from 30 days to as long as 10 years. This comprehensive approach aims to evaluate both immediate treatment success and long-term outcomes for patients with appendicitis.
