## Protocol Section
### Identification Module
**NCT ID:** NCT06413056

**Brief Title:** Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection

**Official Title:** Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection In Preterm Neonates: A Randomized Control Trial

#### Organization Study ID Info
**ID:** micafungin in neonates
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2023-08-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-05-20

**Type:** ACTUAL

#### Start Date
**Date:** 2022-10-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-11
**Study First Submit QC Date:** 2024-05-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ain Shams University

#### Responsible Party

**Investigator Affiliation:** Ain Shams University

**Investigator Full Name:** Mariam Ibrahim

**Investigator Title:** Assistant Professor of Paediatrics, Ain Shams university

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The incidence of fungal infection has increased dramatically over the past few decades.This is due to increase in survival rates of preterm neonates, advances in medical technology and drug therapy, broad spectrum antibiotics and parenteral nutrition . The resistance to antifungal agents has increased. This study will assess the efficacy of micafungin versus amphotericin B in neonates with positive fungal culture.

**Detailed Description:** Neonatal candidiasis is associated with significant mortality and morbidity and high rates of neuro-developmental impairment on follow up Prevalence of invasive fungal infection (IFI) has increased in neonates during the last two decades due to increased survival rate even in the extremely premature neonates. Candida albicans and Candida parapsilosis are responsible for the majority of candidiasis in the neonatal intensive care unit (NICU) According to the European Society for Clinical Microbiology and Infectious Diseases (ESCMID)guidelines published in 2012, Micafungin, amphotericin B deoxycholate, and fluconazole are recommended as first line treatment of invasive candidiasis in neonates Currently, fluconazole and micafungin are among the most frequently used antifungal agents for the treatment of neonatal invasive candidiasis High dose of micafungin (8 to 15 mg/kg/day) can be used with neonates and infant with invasive candidiasis In this study we will explore the effectiveness and safety of micafungin for treatment of candidiasis after fluconazole for preterm neonates with invasive fungal infection and to compare it with amphotericin B.

### Conditions Module

**Conditions:**

- Neonatal Infection

- Invasive Fungal Infections

**Keywords:**

- preterm

- neonate

- invasive fungal infection

- micafungin

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Primary aim; to study the effectiveness of micafungin in treatment of fungal infection in preterm neonates.

Secondary aim; to test the safety of micafungin in treatment of fungal infection in preterm neonates.

Tertiary aim; to compare the effectiveness and safety of micafungin versus amphotericin B in treatment of invasive fungal infection.

##### Masking Info

**Masking:** QUADRUPLE

**Masking Description:** Randomized controlled, Double Blinded Clinical Trial.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 56

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups. Will receive micafungin at a dose of 8 mg/kg/day for 14 day (Auriti et al., 2016).

**Intervention Names:**

- Drug: Micafungin

**Label:** micafungin group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups. Will receive amphotericin B at a dose of 1 mg /kg/day for 14 days (chen et al.,2019).

**Intervention Names:**

- Drug: Amphotericin B

**Label:** amphotericin B group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- micafungin group

**Description:** Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups. Will receive either micafungin or amphotericin B

**Name:** Micafungin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- amphotericin B group

**Description:** Preterm neonate with fungal infection provened by fungal culture and who received fluconazole for at least one week will be divided into two groups.

**Name:** Amphotericin B

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** negative blood culture

**Measure:** resolution of fungal infection

**Time Frame:** 14 days

#### Secondary Outcomes

**Description:** drug complications

**Measure:** complication

**Time Frame:** one month

**Description:** hospital stay

**Measure:** morbidity

**Time Frame:** one month

**Description:** death

**Measure:** mortality

**Time Frame:** one month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient less than 36 weeks gestational age
* started fluconazole either prophylactic or therapeutic dose
* and blood culture is positive for fungal infection.

Exclusion Criteria:

* Any neonate with hepatic dysfunction for any cause (hepatitis or hepatic failure), or with elevation in AST, ALT, alkhaline phosphatase
* Any neonate hypertensive, neutropenic, thrombocytopenic
* Any neonate with elevated renal function
* Any neonate with arrythmia

**Maximum Age:** 28 Days

**Minimum Age:** 1 Day

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Ain Shams University Hospitals

**State:** Abbassia

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000001423

- Term: Bacterial Infections and Mycoses

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: HIGH

- As Found: Fungal Infections

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M1099

- Name: Invasive Fungal Infections

- Relevance: HIGH

- As Found: Invasive Fungal Infections

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000009181

- Term: Mycoses

- ID: D000072742

- Term: Invasive Fungal Infections

### Intervention Browse Module - Ancestors

- ID: D000000563

- Term: Amebicides

- ID: D000000981

- Term: Antiprotozoal Agents

- ID: D000000977

- Term: Antiparasitic Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000000935

- Term: Antifungal Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4002

- Name: Amphotericin B

- Relevance: HIGH

- As Found: Seen

- ID: M255436

- Name: Liposomal amphotericin B

- Relevance: HIGH

- As Found: Seen

- ID: M1829

- Name: Micafungin

- Relevance: HIGH

- As Found: Triggered

- ID: M18296

- Name: Fluconazole

- Relevance: LOW

- As Found: Unknown

- ID: M3904

- Name: Amebicides

- Relevance: LOW

- As Found: Unknown

- ID: M4298

- Name: Antiprotozoal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4294

- Name: Antiparasitic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M6252

- Name: Clotrimazole

- Relevance: LOW

- As Found: Unknown

- ID: M11796

- Name: Miconazole

- Relevance: LOW

- As Found: Unknown

- ID: M4254

- Name: Antifungal Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000666

- Term: Amphotericin B

- ID: C000068538

- Term: Liposomal amphotericin B

- ID: D000077551

- Term: Micafungin

### Misc Info Module

- Version Holder: 2024-05-31
