
Efficacy of IgIv in Patients With IgG Subclass Deficiency and Recurrent Infections
IgG DeficiencyInfectionsThis is the first study, that we are aware of, that will evaluate the efficacy of IgIV in patients with IgG subclass deficiency. Will provide data for further collaboration in extending study to involve other immunological centers in the United States to study patients with similar disease.

To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)...
InfectionPneumonia1 moreTo collect clinical response data with the use of ertapenem in approved indications.

Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections
Cytomegalovirus InfectionCytomegalovirus (CMV) infection is known to cause hearing loss and mental retardation. The purpose of this study is to compare a 6-week course to a 6-month course of the drug valganciclovir in babies born with CMV to assess the safety and efficacy of this treatment. Participants will include 104 infants (30 days old or younger) born with CMV disease. All infants will take valganciclovir by mouth for 6 weeks. At the end of the 6 week period, subjects will be assigned by chance to receive either valganciclovir or placebo (inactive substance) to complete the 6 months of antiviral treatment. Patients will be followed for the study related evaluations of safety, changes to hearing, and developmental milestones for up to 2 years. Patients will be followed by telephone contact for an additional 3 years. Thus, participants may be involved in study related procedures for approximately 5 years.

Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage...
HIV-1 InfectionHIV InfectionBackground: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of subjects after initiation of efavirenz (EFV) and may limit its use in certain patients. Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV given as a stepped dosage over 2 weeks versus the usual dosage. Methods: Randomized, double blind, multicentric clinical trial in which a progressive dosage (arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was compared with conventional administration (arm B: 600 mg qd from the first day). All patients received additional treatment with 2 NRTIs. The incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type scale specifically designed. Efficacy was assessed by percent of virological failures.

Dragon Study (the Safety and Efficacy for Treatment of Patients With Complicated Intra Abdominal...
InfectionIntra-abdominalThe purpose of this study is to assess the safety and efficacy of intravenous administration Moxifloxacin (BAY 12-8039) compared to intravenous ceftriaxone and metronidazole for the treatment of patients with complicated intra abdominal infections. In view of the fact that intra abdominal infections are typically polymicrobial and are often treated empirically, the selected antibacterial agent must cover the likely spectrum of bacterial pathogens. Combination antibiotics therapy has been widely used with great success.

Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections
Skin DiseasesInfectious2 moreThe purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with complicated skin and skin structure infections.

Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure...
Bacterial InfectionThe purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.

Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
HIV -1 InfectionHIV InfectionsThe purpose of this study is: To assess the antiviral activity of PRO 140 To assess the safety and tolerability of PRO 140 To generate additional PK, PD and safety data of PRO 140

Safety, Potential Efficacy, and Pharmacokinetics of PZ-601 in the Treatment of Complicated Skin...
Skin InfectionsThe purpose of this study is to evaluate the potential effect and safety of two different doses of PZ-601 and to compare this with another antibiotic that is approved by the US Food and Drug Administration (also known as FDA) to treat adults with skin and skin structure infections.

Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin...
Skin DiseasesInfectiousThis is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to 17 years, inclusive, with complicated skin and skin structure infections (cSSSI) caused by Gram-positive pathogens.