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NCT ID: NCT02271737 Enrolling by invitation - Neonatal Infection Clinical Trials

Newborn Infection Control and Care Initiative for Health Facilities to Accelerate Reduction of Newborn Mortality

NICCI
Start date: February 2015
Phase: N/A
Study type: Interventional

Newborn mortality continues to be unacceptably high in Cambodia, despite reductions in maternal and under five year old mortality. Evidence exists that a large proportion of newborn mortality globally and in Cambodia is attributable to infections and sepsis. The study proposes a package intervention to address infection control in the perinatal period in facilities and to improve the timeliness of referral of newborns with suspected infections to appropriate health facilities for treatment through upgrading of hygiene practices in facilities and linking of community based volunteers with health facilities and families in the community setting. By delivering a coordinated intervention that combines improved education for health center midwives, village health care workers, and mothers of newborns, along with improved care coordination with increase in number of interactions (points of contact) between mothers and health care personnel, the investigators will see improved knowledge of newborn danger signs among mothers and health care workers, more rapid case detection of significant newborn illnesses, and more rapid and appropriate referral of ill newborns. The investigators also hypothesize that the common causes of newborn sepsis in Cambodia are different from those reported in Western cultures, and that Staphylococcus aureus will be a common pathogen as described in neighboring Laos. The investigators will evaluate the causes of newborn sepsis in the subset of infants referred to Takeo Provincial Hospital.

NCT ID: NCT02270944 Completed - Clinical trials for Infections, Streptococcal

Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine

Start date: November 20, 2014
Phase: Phase 2
Study type: Interventional

The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration), and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and pregnant women in the clinical development program to date.

NCT ID: NCT02269969 Completed - Infection Clinical Trials

Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study

Start date: March 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Effective antimicrobial use in the burn population is important since this population is at an increased risk for infections during their stay in hospital as a result of their burn injury. Tobramycin is an antibiotic that has activity against common burn wound associated pathogens, such as Pseudomonas Aeruginosa, and its use is becoming increasingly relevant due to the increased incidence of bacterial resistance to currently utilized antibiotics. Once daily dosing of tobramycin has been safely and effectively used in the majority of infected patients for many years with the proposed benefits of optimized antibacterial activity and reduced nephrotoxicity compared to traditional dosing. But, the once daily dosing regimen has yet to be validated in the burn population. The purpose of this study is to validate the plausibility of once daily tobramycin dosing in the burn population with intent to determine a safe, effective, and efficient dosing regimen for this population.

NCT ID: NCT02268279 Completed - Bacterial Infection Clinical Trials

Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

Start date: January 2015
Phase: Phase 1
Study type: Interventional

Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17

NCT ID: NCT02267122 Completed - Clinical trials for Incisional Surgical Site Infections

Total Occlusive Ionic Silver-containing Dressing vs Mupirocin Ointment Application vs Conventional Dressing in Elective Colorectal Surgery: Effect on Incisional Surgical Site Infection

Start date: January 2012
Phase: Phase 3
Study type: Interventional

The patients were randomized into 3 groups: those patients undergoing a ionic silver-containing dressing (ISD) (Group 1), those undergoing a Mupirocin ointment application (MOA) (Group 2) and those using a conventional dressing (Group 3) in the surgical wound after finishing an elective colorectal surgery.

NCT ID: NCT02266706 Completed - Clinical trials for Proven or Suspected Gram-negative Bacterial Infection

Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010)

Start date: September 17, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam (MK-7625A) in pediatric participants. In each of the 6 age cohorts, an interim analysis of pharmacokinetics (PK) and safety data was conducted after approximately 3 participants had received the initially proposed dose. The interim analysis was to determine whether the initial dose was appropriate based on pre-defined criteria. If data from the interim analysis demonstrated that the initially proposed dose met the above criteria, enrollment was to continue with the same dose administered to approximately 3 additional participants of the same age range. However, if the interim analysis demonstrated that a new optimized dose was required, the new dose was to be administered to approximately 3 additional participants of the same age range.

NCT ID: NCT02265445 Terminated - Urinary Infection Clinical Trials

Deescalating Carbapenems in Hospital Setting

CARBEPARGNE
Start date: June 2015
Phase: Phase 4
Study type: Interventional

The study aims to evaluate a deescalating therapeutic strategy (switch the carbapenem to another beta-lactam for which the isolated pathogen is susceptible) in patients with well-defined ESBL-PE infections (usual sites of infections and non severe infections).

NCT ID: NCT02263378 Completed - HPV Infection Clinical Trials

A New Supplement for the Immune Response to HPV Infection

Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether a supplement in which ellagic acid plus annona muricata are combined, may modulate the immune response to high risk HPV infection. Sixty women will be enrolled in a randomized, controlled study, having a histological diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the activation of onco suppressor protein by the supplement and secondary outcome is the clearance of HPV infection in the treated group.

NCT ID: NCT02262819 Completed - Clinical trials for Staphylococcus Aureus Skin Infection

Human Immunity Against Staphylococcus Aureus Skin Infection

Start date: October 10, 2014
Phase: Phase 1
Study type: Interventional

Background: - Staphylococcus aureus, or staph, is commonly found on the skin and in the respiratory system. Sometimes people who get sick with staph infection do not get better with standard treatment. These staph infections can be serious and even deadly. Researchers want to find out why some people are more likely to get the infection. Objectives: - To look at the immune response of the skin when it is exposed to bacteria. Eligibility: - People age 2 65 with hyper IgE syndrome (HIES) and those with recurrent staph infections. - Healthy volunteers. Design: - Participants will be screened with medical history, physical exam, and blood tests. - Over 1 5 days, participants may have blood tests and a skin and nasal swab. They may have additional tests if needed. If they had a recent biopsy, researchers may ask for a sample from it. - Some participants will spend the night at the clinic. Their vital signs will be taken and they will have blood drawn. Some participants will take aspirin or ibuprofen starting 2 days before their stay. - Some participants will have blisters created on the inside of their forearm. Suction will pull a layer of skin from their arm. Skin will be removed. Different solutions will be applied to the blisters. Up to 3 biopsies may be taken. - Children will not have blood tests or biopsies. - Participants will be called every day for 10 days, then at 30 days after the procedure. - Participants will have a follow-up visit 10 days after the procedure. - Participants who did not get blisters or biopsies will not have any follow-up appointments.

NCT ID: NCT02262403 Active, not recruiting - Hookworm Infection Clinical Trials

Hookworm Immune Regulation Project

HIRP-01
Start date: August 1, 2014
Phase: N/A
Study type: Interventional

The main objective of this study is to characterize the regulatory immune response induced by hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution after infection treatment and during potential naturally reinfection.