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NCT ID: NCT03894046 Completed - Bacteremia Clinical Trials

Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex

ATTACK
Start date: September 5, 2019
Phase: Phase 3
Study type: Interventional

This is a 2-part study, with Part A being the randomized, controlled portion of the study in patients with ABC hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or bacteremia. Part B is the single-group portion of the study and includes ABC infections that are resistant to or have failed colistin or polymyxin B treatment, as detailed in the inclusion criteria.

NCT ID: NCT03891446 Enrolling by invitation - Ocular Hypertension Clinical Trials

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

Maia
Start date: March 27, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

NCT ID: NCT03887520 Completed - Clinical trials for Cardiovascular Disease and Lipoprotein(a)

Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)

Start date: November 27, 2018
Phase: N/A
Study type: Interventional

The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).

NCT ID: NCT03881228 Completed - Tuberculosis Clinical Trials

Patient Centered Intervention to Prevent Tuberculosis Among Children Under Five Years Old

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Isoniazid preventive therapy (IPT) reduces the risk of tuberculosis in 60%. Young children are at higher risk of developing severe forms of TB, though this can be prevented with a full course of IPT. Preliminary data indicate that 60% of eligible children start IPT, and 30% complete it. Furthermore, children can be exposed to more than one case of TB in the household. Adults exposed to TB in the household setting are not necessarily aware of their risk. Uncertainties in the decisions of staff to prescribe IPT and limited health literacy among caretakers and families contribute to this. The investigators will determine the efficacy of an intervention package to increase IPT adherence and completion among children < 5 years old exposed to TB in the household. The investigators will assess the efficacy of the intervention by 1) measuring IPT completion at 6 months after treatment initiation and by 2) determining adherence to IPT by measuring isoniazid in urine at weeks 2, 8 and 24 in a random cluster sample of 10 health facilities and 20 control facilities with 10 children included in each facility (100 in intervention and 200 in control). The investigators will measure fidelity and reach, and acceptability among caretakers and health staff. The intervention package will consist of: 1) educational booklet for caretakers explaining why IPT needs to be given 2) a children's storybook, with weekly installments, over the 6-month course of IPT as a non-monetary incentive and 3) short messages services (SMS) reminders delivered to the caretaker for the weekly pick-up In September 2020, the protocol was updated to adapt to the COVID19 situation in Lima. One of the secondary outcome (isoniazid concentration in urine) was cancelled and the full intervention (educational booklet, weekly children storybook and weekly SMS) is now delivered through WhatsApp.

NCT ID: NCT03862196 Recruiting - HIV Clinical Trials

Efficacy of SMS to Improve Early Retention in HIV Care for PLWH in Lima

Start date: December 21, 2018
Phase: N/A
Study type: Interventional

Randomized controlled study that will evaluate the effect of a text message-based strategy to improve retention in HIV care.

NCT ID: NCT03860844 Terminated - Clinical trials for Acute Myeloid Leukemia

Isatuximab in Combination With Chemotherapy in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia

ISAKIDS
Start date: August 6, 2019
Phase: Phase 2
Study type: Interventional

Primary Objective: Evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) Secondary Objectives: - Safety and tolerability assessments - Assessment of infusion reactions (IRs) - Pharmacokinetics (PK) of isatuximab - Minimal residual disease - Overall response rate - Overall survival - Event free survival - Duration of response - Relationship between clinical effects and CD38 receptor density and occupancy

NCT ID: NCT03847428 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

EMERALD-2
Start date: April 29, 2019
Phase: Phase 3
Study type: Interventional

A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

NCT ID: NCT03840148 Completed - Clinical trials for Urinary Tract Infections

Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections

CERTAIN-1
Start date: August 7, 2019
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of cefepime/VNRX-5133 compared with meropenem in both eradication of bacteria and in symptomatic response in patients with cUTIs.

NCT ID: NCT03830866 Completed - Clinical trials for Locally Advanced Cervical Cancer

Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)

CALLA
Start date: February 15, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, multi-center, double-blind, placebo-controlled, global, Phase III study to determine the efficacy and safety of durvalumab + Chemoradiotherapy versus Chemoradiotherapy alone as treatment in Women With Locally Advanced Cervical Cancer

NCT ID: NCT03827811 Recruiting - Clinical trials for Multi-drug Resistant Tuberculosis

Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis

PandrTB
Start date: January 30, 2020
Phase:
Study type: Observational

PandrTB is a study of the pharmacokinetics(PK) and pharmacodynamics(PD) of bedaquiline, delamanid, clofazimine, linezolid, moxifloxacin, levofloxacin and pyrazinamide used in novel combinations to treat multidrug-resistant tuberculosis(MDR-TB).