
Pharmacokinetic of Mefloquine-Artesunate in Plasmodium Falciparum Malaria Infection in Pregnancy...
Plasmodium Falciparum MalariaMalaria in pregnancy is a major public health problem in Sub-Saharan Africa. Over the past decades, P. falciparum has shown increasing resistance to chloroquine and Sulphadoxine-Pyrimethamine, which has prompted a change in treatment approach; artemisinin containing combination therapies (ACTs) are now the standard treatment of P. falciparum malaria in areas with established resistance to traditional therapies. However, a standard approach for using ACT in pregnancy does not exist in Africa, where some countries keep on using quinine, while others allow the use of ACTs. Thus, there is need of establishing the safety and efficacy of ACTs in malaria-infected pregnant women. Since the pharmacokinetic of antimalarials may be altered during pregnancy and since available pharmacokinetic data are still somewhat limited, we propose to carry out a study confirming or disproving existing pharmacokinetic data (collected in South-East Asia), before starting any larger African efficacy and safety trials. The fixed-dose combination mefloquine-artesunate (MQ-AS), developed by the Drugs for Neglected Diseases Initiative, will be used in the study, which will compare the pharmacokinetics of MQ-AS for treatment of P.falciparum in 24 pregnant women in the second and third trimesters, to the pharmacokinetics of this regimen in 24 matched non-pregnant P.falciparum infected women. The study will be carried out in Burkina Faso.

Multicenter Infection Surveillance Study Following Open Heart Surgery
SurgeryPneumonia1 moreThe main goals of the study are as follows: (1) to determine the correlation between pain management using continuous infusion of local anesthetics and the incidence of pneumonia and surgical infection in cardiac surgery patients; and (2) to evaluate the relationship between hospital-acquired pneumonia and surgical infection and patient outcomes, including length of hospital stay.

Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections...
Urinary Tract InfectionTo assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR) tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet 500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial urinary tract infections (cUTI).

PRO 140 by IV Administration in Adults With HIV-1 Infection
HIV InfectionsThe purpose of this study is: To assess and characterize the PK and PD of PRO 140 administered IV To assess the antiviral activity of PRO 140 To assess the safety and tolerability of PRO 140

Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
Bacteria InfectionRespiratory Tract InfectionsOur hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for Bronchopulmonary Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection

MAKE IT CLEAN, Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients...
InfectionTo determine the effect of scar tissue removal on the rate of infection and any other complications such as bleeding in patients with an ICD or pacemaker who have the device generator or leads replaced or repositioned.

PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
Respiratory Tract InfectionsPrimary - To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma after second period of treatment Secondary To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment To evaluate loss of working or study days after second period of treatment To evaluate the safety and tolerability of Pulmonarom in the population under study

Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection
HIV InfectionsThe objective of the study is to compare two different doses of Peg-INF-α-2A (90 or 180 ug/wk) for their ability to maintain viral control when initiated 5 weeks before ART (antiretroviral therapy) interruption in HIV positive, ART-suppressed subjects (viral load <50 copies/ml) as determined by observing the percentages of viral load measurements <400 copies/ml between the two arms over a 24-week period, corresponding to the Pegasys monotherapy period (exclusive of dual ART/Pegasys 5-week period). Primary analysis will be an "intent to treat" analysis and will address the hypothesis that two different doses of Peg-INF-α-2A (90 and 180 ug/week) will be similarly effective at inhibiting viral replication.

Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients
Cytomegalovirus InfectionThe objectives of this study were: To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days of treatment. To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.). Evaluate the security of this treatment with valganciclovir.

Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract...
Complicated Urinary Tract InfectionThe purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.