Clinical trials: Resistant Infection
HIV Infections
Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV
A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has been shown to be an effective way of reducing the risk of mother-to-child transmission (MTCT) of HIV.
- Trial name
- P1060 (NCT00307151)
- Testing
- Lamivudine, Lopinavir/ritonavir, Nevirapine
- Where
- 10 sites in India, Malawi and 5 more
- Volunteers
- 452 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Methicillin-resistant Staphylococcus Aureus
Cluster Randomized Trial of Hospitals to Assess Impact of Targeted Versus Universal Strategies to Reduce Methicillin-resistant Staphylococcus Aureus (MRSA) in Intensive Care Units (ICUs)
The Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate MRSA (REDUCE MRSA) Trial is a cluster randomized trial of the comparative effectiveness of three strategies to prevent methicillin-resistant…
- Trial name
- REDUCE-MRSA (NCT00980980)
- Testing
- Chlorhexidine bath and nasal mupirocin
- Where
- 42 sites in United States
- Volunteers
- 74,256 people
- Sponsor
- Harvard Pilgrim Health Care
Vesicoureteral Reflux, Urinary Tract Infections
Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy…
- Trial name
- RIVUR (NCT00405704)
- Testing
- Trimethoprim-Sulfamethoxazole
- Where
- 19 sites in United States
- Volunteers
- 607 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
HIV-1-infection
Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant Virus
The primary objective of this study is to evaluate the short-term antiviral potency of GS-9131 functional monotherapy compared to placebo-to-match (PTM) GS-9131, each administered once daily with the existing failing…
- Trial name
- NCT03472326
- Testing
- GS-9131, BIC, TAF
- Where
- 2 sites in Uganda, Zimbabwe
- Volunteers
- 21 people
- Sponsor
- Gilead Sciences
Staphylococcus Aureus
Mupirocin-Iodophor ICU Decolonization Swap Out Trial
The Swap Out Trial is a cluster randomized controlled trial of HCA hospitals, evaluating the non-inferiority of two decolonization regimens: Arm 1 Routine Care: ICU nasal decolonization with mupirocin twice daily for 5 days in…
- Trial name
- NCT03140423
- Testing
- Arm 1. Routine Care (Mupirocin/CHG), Arm 2. Iodophor/CHG Decolonization
- Where
- 137 sites in United States
- Volunteers
- 353,323 people
- Sponsor
- Harvard Pilgrim Health Care
HIV
Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects.
- Trial name
- NCT02707861
- Testing
- ibalizumab, Optimized Background Regimen
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 79 people
- Sponsor
- TaiMed Biologics Inc.
HCV Infection
A Follow-up Assessment of Resistance to ABT-333 in Hepatitis C Virus (HCV)-Infected Subjects Who Have Received ABT-333 in ABT-333 Studies
The purpose of this follow-up study is to evaluate the frequency and persistence of specific viral mutations in response to treatment with ABT-333 (dasabuvir).
- Trial name
- NCT00726882
- Testing
- Blood sample collection only, ABT-333
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 35 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Cystic Fibrosis, Methicillin-resistant Staphylococcus Aureus
Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)
Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009).
- Trial name
- STAR-Too (NCT01349192)
- Testing
- Rifampin, Trimethoprim/Sulfamethoxazole, Minocycline
- Where
- 13 sites in United States
- Volunteers
- 47 people
- Sponsor
- University of North Carolina, Chapel Hill
Tuberculosis
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen (BR) of antibacterial drugs as treatment for MDR-TB
- Trial name
- NCT00910871
- Testing
- TMC207, Background Regimen (BR) for MDR-TB
- Where
- 27 sites in China, Estonia and 10 more
- Volunteers
- 241 people
- Sponsor
- Janssen Infectious Diseases BVBA
Abscess
Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections
The purpose of this study is to determine if soft tissue infections in pediatric patients can be more accurately diagnosed (i.e.
- Trial name
- NCT00595881
- Testing
- Bedside emergency ultrasound
- Where
- United States
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Cytomegalovirus (CMV)
Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients
This study will assess safety, antiviral activity, and pharmacokinetics of different doses of maribavir administered orally for up to 24 weeks for treatment of CMV infections that are resistant or refractory to treatment with…
- Trial name
- NCT01611974
- Testing
- Maribavir
- Where
- 32 sites in United States
- Volunteers
- 120 people
- Sponsor
- Shire
Healthcare Associated Pneumonia
Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia
Background The prediction of multi-drug resistant (MDR) pathogens is a key issue in the management of health-care associated pneumonia (HCAP).
- Trial name
- NCT01966796
- Where
- Taiwan
- Volunteers
- 530 people
- Sponsor
- Far Eastern Memorial Hospital
Bacterial Pneumonia
Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia
- Trial name
- CAP (NCT00621504)
- Testing
- Ceftaroline fosamil for Injection, IV Ceftriaxone, Clarithromycin
- Where
- 168 sites in United States, Argentina and 21 more
- Volunteers
- 606 people
- Sponsor
- Forest Laboratories
Infective Endocarditis
Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)
multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the treatment of SAIE
- Trial name
- NCT00638157
- Testing
- daptomycin, daptomycin and gentamicin
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Multidrug Resistant Tuberculosis
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen (OBR) of other anti-tuberculosis drugs in…
- Trial name
- NCT01859923
- Testing
- Delamanid, Delamanid Pediatric Formulation (DPF), Optimized Background Regimen (OBR)
- Where
- 3 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Human Immunodeficiency Virus
Evaluation of Kaletra Therapy Over the Long-term
Long term observation of patients under lopinavir/ritonavir containing therapy
- Trial name
- NCT01083810
- Testing
- Lopinavir/Ritonavir (Kaletra)
- Where
- 90 sites in Germany
- Volunteers
- 284 people
- Sponsor
- Abbott
Infection With Multi-drug Resistant Organisms
FMT for Multidrug Resistant Organism Reversal
This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with recurrent MDRO infections due to organisms of…
- Trial name
- NCT02312986
- Testing
- Fecal microbiota transplantation (FMT)
- Volunteers
- 1 people
- Sponsor
- Washington University School of Medicine
Hepatitis C, Medication Adherence
Patient-Centered Models of HCV Care for People Who Inject Drugs
People who inject drugs (PWID) have higher rates of hepatitis C virus (HCV) than do other groups. Effective, safe new treatments called direct-acting antiviral agents (DAAs) have been developed recently.
- Trial name
- HERO (NCT02824640)
- Testing
- Patient Navigation, modified Directly Observed Therapy
- Where
- United States
- Volunteers
- 755 people
- Sponsor
- Prisma Health-Upstate
HIV
Emtricitabine/Tenofovir Alafenamide as Salvage ART
Background: HIV attacks the immune system. Antiretroviral therapy (ART) is a combination of drugs used for treating HIV infection. For some people, ART drugs stop working against their HIV.
- Trial name
- NCT02556333
- Testing
- FTC/TAF
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, AIDS
Resistance Testing to Improve Management of Virologic Failure in Sub-Saharan Africa
The study design is an open-label, randomized controlled trial. The study will be conducted at study sites in Uganda and South Africa.
- Trial name
- REVAMP (NCT02787499)
- Testing
- HIV-1 RNA Resistance Testing
- Where
- 2 sites in South Africa, Uganda
- Volunteers
- 840 people
- Sponsor
- Massachusetts General Hospital