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National Institute For Infectious Diseases Lazzaro Spallanzani

Research site

Italy Via Portuense 292, 00149 Rome, Italy

  • 8 trials recruiting
  • HIV infection · Post-acute COVID-19 syndrome · Acute respiratory failure
  • Adults and children

About Specializations

National Institute For Infectious Diseases Lazzaro Spallanzani in Rome, Italy specialises in clinical trials of conditions such as HIV infection, Post-acute COVID-19 syndrome, Acute respiratory failure, Bacteraemia, and other specialisations. This site conducts important research.

Main research areas of the site

Bacterial Infections and Mycoses

At the National Institute For Infectious Diseases Lazzaro Spallanzani, researchers are advancing treatments for serious bacterial and fungal diseases such as tuberculosis, bloodstream infections caused by resistant Enterobacteriaceae, and chronic pulmonary aspergillosis. Trials aim to evaluate safety and effectiveness of host‑directed adjuncts, optimized antibiotic dosing, and new antifungal agents to improve patient outcomes.

  • Adjunctive host‑directed therapy with cysteamine for pulmonary tuberculosis
  • Comparative efficacy of olorofim versus standard amphotericin B for invasive aspergillosis
  • Optimized high‑dose rifampicin regimen to reduce hepatotoxicity in TB patients
  • Rezafungin treatment for chronic pulmonary aspergillosis with limited options
  • Non‑inferiority trial of piperacillin‑tazobactam versus meropenem for cephalosporin‑resistant bacteremia

These studies involve a multidisciplinary team of seven investigators and reflect the institute’s commitment to tackling antimicrobial resistance and difficult‑to‑treat fungal infections.

Immune System Diseases

The department focuses on disorders of immune regulation, including post‑acute COVID‑19 syndrome and long COVID. Clinical work evaluates immunomodulatory drugs such as anakinra and tozorakimab, and monitors immune recovery after monoclonal antibody therapy, with the goal of reducing persistent symptoms and improving quality of life.

  • Anakinra for symptom relief in post‑COVID respiratory syndrome
  • Tozorakimab added to standard care for severe viral lung infection
  • Longitudinal assessment of humoral and cellular immunity after monoclonal antibody treatment
  • Identification of biomarkers predicting response to immune‑modulating therapies
  • Evaluation of host‑directed strategies to mitigate chronic inflammation in long COVID

The research leverages the institute’s expertise in immunology to develop therapies that target the underlying immune dysregulation driving these conditions.

Respiratory Tract Diseases

Clinical investigations address acute and chronic lung conditions, notably COVID-19 pneumonia, severe viral lung infections, and respiratory forms of tuberculosis. The aim is to test novel antivirals, host‑targeted adjuncts, and optimized antimicrobial regimens to reduce mortality and improve pulmonary function.

  • Cysteamine as adjunct therapy for hospitalized COVID‑19 pneumonia patients
  • Host‑directed treatment with tozorakimab for viral lung infection requiring supplemental oxygen
  • High‑dose rifampicin safety assessment in pulmonary tuberculosis
  • Safety and efficacy of new antifungal agents for chronic pulmonary aspergillosis
  • Patient‑reported outcome measures to evaluate respiratory quality of life during trials

These projects integrate pulmonology and infectious disease expertise to deliver comprehensive care for patients with complex respiratory infections.

Virus Diseases

The institute’s virology program targets chronic viral infections such as HIV, Hepatitis B, and Hepatitis D. Ongoing trials assess novel antiretroviral combinations, long‑acting injectable regimens, and antiviral nucleic‑acid therapies to achieve sustained viral suppression and simplify treatment.

  • Switch to bictegravir/lenacapavir versus continued Biktarvy in virologically suppressed HIV patients
  • Early switch to a two‑drug dolutegravir/lamivudine regimen after viral suppression
  • Weekly oral GS‑1720/GS‑4182 fixed‑dose combination versus standard Biktarvy
  • Long‑acting cabotegravir/rilpivirine administered every two months compared with oral ART
  • Bepirovirsen therapy for HIV/HBV coinfected individuals
  • BJT‑778 versus bulevirtide for chronic hepatitis D infection

With seven dedicated investigators, the site contributes valuable data to global efforts aimed at improving viral disease management and patient adherence.

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Site location
Via Portuense 29200149 RomeItaly
Recruiting now
8 trials
Conditions studied
15

More sites in RomeItaly

Recruiting now

Ongoing trials

Clinical trials currently enrolling participants at this site.

Condition
Type of trial
Recruitment status
Quick filters

28 clinical trials

Study on Tozorakimab for Patients Hospitalized with Severe Viral Lung Infections Needing Oxygen

Investigational
Countries:ItalyItaly
  • Participants:18–64 years · 65+ years
  • Substances:Tozorakimab
  • Sponsor:AstraZeneca AB

HIV infection

Recruiting

Switching to Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults with HIV-1: A Phase 3 Randomized Study

Registered drugNo placebo
Countries:ItalyItaly
  • Participants:18–64 years · 65+ years
  • Substances:Abacavir
  • Sponsor:Gilead Sciences Inc.

HIV infection

Recruiting

Switching to lenacapavir-based drug combination vs cabotegravir-based drug combination in virologically suppressed adults with HIV-1

Registered drugNo placebo
Countries:ItalyItaly
  • Participants:18–64 years · 65+ years
  • Substances:Cabotegravir
  • Sponsor:Gilead Sciences Inc.

HIV infection

Recruiting

A study testing VH4524184 with emtricitabine and tenofovir alafenamide compared to dolutegravir and lamivudine in adults with HIV-1 who have not received treatment before

Registered drugNo placebo
Countries:ItalyItaly
  • Participants:18–64 years · 65+ years
  • Substances:Dolutegravir Sodium
  • Sponsor:Viiv Healthcare UK Limited

Bacteraemia

Recruiting

Comparing piperacillin-tazobactam and meropenem for treating bloodstream infections caused by cephalosporin-resistant bacteria in adult patients

Registered drugNo placebo
Countries:ItalyItaly
  • Participants:18–64 years · 65+ years
  • Substances:Meropenem Anhydrous
  • Sponsor:Azienda Ospedaliero Universitaria Di Modena

Hepatitis D

Recruiting

Clinical Trial for Patients with Chronic Hepatitis D: Comparing Brelovitug and Bulevirtide Treatments

Registered drugNo placebo
Countries:ItalyItaly
  • Participants:18–64 years · 65+ years
  • Substances:BJT-778
  • Sponsor:Mirum Pharmaceuticals Inc.

Study on Anakinra for Patients with Long COVID and Ongoing Respiratory Symptoms

Registered drug
Countries:ItalyItaly
  • Participants:18–64 years · 65+ years
  • Substances:Anakinra
  • Sponsor:Hellenic Institute For The Study Of Sepsis

Study of cysteamine combined with standard tuberculosis treatment in adults with pulmonary tuberculosis

Registered drugNo placebo
Countries:ItalyItaly
  • Participants:18–64 years
  • Substances:Mercaptamine
  • Sponsor:National Institute For Infectious Diseases Lazzaro Spallanzani

A study to evaluate the effectiveness of upadacitinib and pirfenidone in reducing symptom severity in patients with Long Covid

Registered drug
Countries:ItalyItaly
  • Participants:18–64 years
  • Substances:Pirfenidone
  • Sponsor:Dr. Douglas D. Fraser

HIV infection

Not yet recruiting

Study of Weekly Oral GS-1720 and GS-4182 for People with HIV-1 Who Are Virologically Suppressed

Registered drugNo placebo
Countries:ItalyItaly
  • Participants:18–64 years · 65+ years
  • Substances:Bictegravir
  • Sponsor:Gilead Sciences Inc.
Countries:ItalyItaly
  • Participants:18–64 years · 65+ years
  • Substances:Cilgavimab
  • Sponsor:National Institute For Infectious Diseases Lazzaro Spallanzani

Tuberculosis

Not yet recruiting

Study on the Safety and Tolerability of Higher Dose Rifampicin for Tuberculosis Patients

Registered drugNo placebo
Countries:ItalyItaly
  • Participants:18–64 years · 65+ years
  • Substances:Rifampicin
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