Study on the Effectiveness and Safety of Amoxicillin, Clavulanic Acid, and Metronidazole for Treating Acute Appendicitis in Children Aged 7 to 18

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What is this study about?

This clinical trial is focused on studying the treatment of acute non-complicated appendicitis in children aged 7 to 18 years. The trial aims to explore the effectiveness and safety of a conservative treatment approach, which means managing the condition without surgery. The study will use several medications, including Amoxicillin and Clavulanic Acid (found in products like Amoksiklav and Medoclav), Metronidazole, Ampicillin, and Ceftazidime Pentahydrate. These medications are commonly used antibiotics that help fight infections.

The purpose of the study is to evaluate how well these treatments work in managing appendicitis without the need for surgery, as well as to assess the cost-effectiveness of this approach. Participants in the study will receive treatment for a total of 10 days, with 3 days of in-patient care followed by 7 days of out-patient care. The study will also include follow-up checks at one month and one year to monitor the long-term outcomes of the treatment.

This trial is designed to provide new insights into early diagnosis and treatment options for children with appendicitis, potentially offering a less invasive alternative to surgery. By participating in this study, researchers hope to establish new criteria for diagnosing and treating this condition effectively and economically.

1 in-patient treatment

The treatment begins with a 3-day in-patient stay at the medical facility.

During this period, the patient receives medications to manage acute non-complicated appendicitis.

The medications include amoxicillin with clavulanic acid in the form of film-coated tablets for oral use, and metronidazole as a solution for infusion administered intravenously.

The specific dosage and frequency of administration are determined by the healthcare provider based on the patient’s condition.

2 out-patient treatment

Following the in-patient treatment, the patient continues with a 7-day out-patient treatment.

During this phase, the patient may continue taking amoxicillin with clavulanic acid orally as prescribed.

Regular check-ups may be scheduled to monitor the patient’s recovery and response to the treatment.

3 follow-up

After completing the out-patient treatment, the patient enters the follow-up phase.

The first follow-up occurs 1 month after the treatment to assess the patient’s health and ensure no complications have arisen.

A second follow-up is scheduled for 1 year post-treatment to evaluate the long-term outcomes and effectiveness of the conservative treatment approach.

Who Can Join the Study?

Age between 7 and 18 years old.
Diagnosed with primary acute non-complicated appendicitis. This means the appendix is inflamed but not severely damaged or ruptured.
ALVORADO score of 7 or higher. This is a scoring system used to help diagnose appendicitis based on symptoms and test results.
Experiencing pain in the right lower part of the belly.
Blood test showing C-reactive protein level of 10 mg/L or less. This protein increases when there is inflammation in the body.
If tested, Il-6 level should be 39.2 pg/mL or less. Il-6 is a substance in the blood that can indicate inflammation.
Ultrasound showing signs of acute appendicitis. An ultrasound is an imaging test that uses sound waves to look at organs inside the body.

Who Cannot Join the Study?

Patients who are not between the ages of 7 and 18.
Patients who do not have acute non-complicated appendicitis. This means the appendix is inflamed but not severely infected or burst.
Patients who have other medical conditions that could interfere with the study.
Patients who are unable to follow the study procedures or instructions.
Patients who have participated in another clinical trial recently.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergic reactions.
Patients who are taking medications that could affect the study results.

Where you can join this trial?

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Site Name	City	Country	Status
Btvwf Kafuuoff Uqqvwrfsfcffq Sjqjdubp Vodu	Riga	Latvia

Trial status

Country	Status	Recruitment Start
Latvia	Not yet recruiting	02.09.2021

Trial locations

Investigated drugs:

Amoxicillin is an antibiotic used to treat infections caused by bacteria. In this trial, it is used to help treat non-complicated acute appendicitis in children by reducing the infection and inflammation.

Metronidazole is another antibiotic that works by stopping the growth of bacteria. It is used in combination with other medications to treat appendicitis by targeting specific bacteria that may be causing the infection.

Ibuprofen is a medication that helps reduce pain and inflammation. In this trial, it is used to manage the pain associated with appendicitis and to help reduce inflammation in the body.

Paracetamol is a pain reliever and a fever reducer. It is used in this trial to help manage pain and reduce fever in children with appendicitis.

Investigated diseases:

Appendicitis

Acute Non-Complicated Appendicitis – This condition involves inflammation of the appendix, a small pouch attached to the large intestine. It typically occurs in children and adolescents, causing symptoms like abdominal pain, particularly in the lower right side, along with nausea and fever. The inflammation is considered non-complicated when it hasn’t led to severe issues like rupture or abscess formation. The progression involves increasing pain and discomfort, which may worsen over time if not addressed. In non-complicated cases, the inflammation may resolve with appropriate management. The condition requires careful monitoring to prevent complications.

Trial ID:

2025-520496-19-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Amoxicillin, Clavulanic Acid, and Metronidazole for Treating Acute Appendicitis in Children Aged 7 to 18

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?