AMBITION-cm: intermittent high dose AmBisome on a high dose fluconazole backbone for cryptococcal meningitis induction therapy in sub-Saharan Africa: study protocol for a randomized controlled trial

Abstract Introduction: Surgical Site Infections (SSIs) are infections that occur at or near the surgical incision within 30 days of the surgery. SSIs are the commonest form of hospital acquired infections in sub Saharan Africa with estimates between 15%-45%. Cesarean section (CS) is the single most important risk factor for postpartum infections, carrying a 5 to 20-fold increase in the risk of developing sepsis, with an even higher risk when the operation is an emergency. In sub Saharan Africa, the leading cause of maternal mortality is puerperal sepsis. There is a need for simple interventions that can reduce this burden of SSI in the limited resource settings. Therefore, the purpose of this study was to measure the effectiveness of chloroxylenol in reducing the incidence of post Cesarean section surgical site infections at Mbarara Regional Referral Hospital (MRRH).Methods: We conducted a single blinded randomized controlled trial at MRRH maternity ward in which women due for CS were randomized into either control or intervention arms. The intervention was a complete body bath with chloroxylenol antiseptic soap before the operation, while the control arm study participants received a standard pre-operative preparation procedures according to the existing ward protocol. All participants were followed up for 30 days and assessed using a standard SSI screening tool. Results: Ninety-six women were randomized, and 48 were assigned to either arm. The overall incidence of SSI was 30.21%. The incidence of SSI was significantly lower in the intervention compared to the control arm, at 6.25% in the intervention arm versus 54.17% in the control arm (p value<0.001). Chloroxylenol bath was protective of SSI with a 90% risk reduction for SSI (95% confidence interval of 67% – 97%). Conclusion: A preoperative bath with chloroxylenol for pregnant mothers is associated with a significantly lower risk of post Cesarean section surgical site infections. Health facilities with a high burden of post SSI should consider adding this simple and effective intervention to the existing infection prevention measures. Clinical Trials.gov registration (NCT03544710).

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An open label randomized controlled trial of tamoxifen combined with amphotericin B and fluconazole for cryptococcal meningitis

eLife ◽

10.7554/elife.68929 ◽

2021 ◽

Vol 10 ◽

Author(s):

Nguyen Thi Thuy Ngan ◽

Nhat Thanh Hoang Le ◽

Nguyen Ngo Vi Vi ◽

Ninh Thi Thanh Van ◽

Nguyen Thi Hoang Mai ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cryptococcal Meningitis ◽

Standard Care ◽

Therapeutic Potential ◽

Controlled Trial ◽

High Dose ◽

Open Label ◽

Randomized Controlled ◽

Cancer Agent

Background: Cryptococcal meningitis has high mortality. Flucytosine is a key treatment but is expensive and rarely available. The anti-cancer agent tamoxifen has synergistic anti-cryptococcal activity with amphotericin in vitro. It is off-patent, cheap, and widely available. We performed a trial to determine its therapeutic potential.Methods:Open label randomized controlled trial. Participants received standard care - amphotericin combined with fluconazole for the first two weeks - or standard care plus tamoxifen 300mg/day. The primary end point was Early Fungicidal Activity (EFA) - the rate of yeast clearance from cerebrospinal fluid (CSF). Trial registration https://clinicaltrials.gov/ct2/show/NCT03112031 .Results: 50 patients were enrolled, (median age 34 years, 35 male). Tamoxifen had no effect on EFA (- 0.48log10 colony-forming units/mL/CSF control arm versus -0.49 tamoxifen arm, difference - 0.005log10CFU/ml/day, 95%CI: -0.16, 0.15, P=0.95). Tamoxifen caused QTc prolongation.Conclusion: High dose tamoxifen does not increase the clearance rate of Cryptococcus from CSF. Novel, affordable therapies are needed.Funding:The trial was funded through the Wellcome Trust Asia Programme Vietnam Core Grant 106680 and a Wellcome Trust Intermediate Fellowship to JND grant number WT097147MA.

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AMBITION?cm: AMBIsome Therapy Induction OptimizatioN - Intermittent high dose AmBisome® on a high dose fluconazole backbone for cryptococcal meningitis induction therapy in sub-Saharan Africa

http://isrctn.org/> ◽

10.1186/isrctn10248064 ◽

2014 ◽

Author(s):

Thomas Harrison

Keyword(s):

Induction Therapy ◽

Cryptococcal Meningitis ◽

Sub Saharan Africa ◽

High Dose ◽

Sub Saharan

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Short-term Effects of Calcium and Vitamin D Supplementation in Postmenopausal Hypertensive Patients in sub-Saharan Africa: A Double Blinded Randomized Controlled Trial

Acta Scientific Women's Health ◽

10.31080/aswh.2021.si.03.0010 ◽

2021 ◽

Vol 1 (3) ◽

pp. 59-64

Author(s):

Chris Nadège Nganou-Gnindjio ◽

Vicky Jocelyne Ama Moor ◽

Constant Anatole Pieme ◽

Guy Sadeu Wafeu ◽

Ingrid Ngandjeu Kamtchoum ◽

...

Keyword(s):

Vitamin D ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Sub Saharan Africa ◽

Short Term ◽

Hypertensive Patients ◽

Randomized Controlled ◽

Sub Saharan ◽

Double Blinded

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High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-015-0761-7 ◽

2015 ◽

Vol 16 (1) ◽

Cited By ~ 7

Author(s):

Harald Rief ◽

Sonja Katayama ◽

Thomas Bruckner ◽

Stefan Rieken ◽

Tilman Bostel ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Bone Metastases ◽

Study Protocol ◽

Controlled Trial ◽

External Beam Radiotherapy ◽

High Dose ◽

External Beam ◽

Single Fraction ◽

Randomized Controlled ◽

Spinal Bone Metastases

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Effectiveness of preoperative bath using Chloroxylenol antiseptic soap on the incidence of post emergency Cesarean section surgical site infection at Mbarara Regional Referral hospital, Uganda: a Randomized Controlled trial

10.21203/rs.2.22140/v1 ◽

2020 ◽

Author(s):

Henry Lukabwe ◽

Rodgers Kajabwangu ◽

Dale Mugisha ◽

Horace Mayengo ◽

Baraka Munyanderu ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Surgical Site Infections ◽

Sub Saharan Africa ◽

P Value ◽

Prevention Measures ◽

Randomized Controlled ◽

Emergency Cesarean ◽

Sub Saharan

Abstract Introduction: Surgical Site Infections (SSIs) are infections that occur at or near the surgical incision within 30 days of the surgery. SSIs are the commonest form of hospital acquired infections in sub Saharan Africa with estimates between 15%-45%. Cesarean delivery is the single most important risk factor for postpartum infections, carrying a 5 to 20-fold increase in the risk of developing sepsis, with an even higher risk when the operation is an emergency. In sub Saharan Africa, the leading cause of maternal mortality is puerperal sepsis. There is a need for simple interventions that can reduce this burden of SSI in the limited resource settings. Therefore, the purpose of this study was to measure the effectiveness of chloroxylenol in reducing the incidence of post Cesarean section surgical site infections at Mbarara Regional Referral Hospital.Methods: We conducted a single blinded randomized controlled trial at MRRH maternity ward in which women due for CS were randomized into either control or intervention arms. The intervention was a complete body bath with chloroxylenol antiseptic soap before the operation, while the control arm study participants received a standard pre-operative preparation procedures according to the existing ward protocol. All participants were followed up for 30 days and assessed using a standard SSI screening tool.Results: Ninety-six women were randomized, and 48 were assigned to either arm. The overall incidence of SSI was 30.21%. The incidence of SSI was significantly lower in the intervention compared to the control arm, at 6.25% in the intervention arm versus 54.17% in the control arm (p value<0.001). Chloroxylenol bath was protective of SSI with a 90% risk reduction for SSI (95% confidence interval of 67% – 97%).Conclusion: A preoperative bath with chloroxylenol for pregnant mothers is associated with a significantly lower risk of post Cesarean section surgical site infections. Health facilities with a high burden of post SSI should consider adding this simple and effective intervention to the existing infection prevention measures. Clinical Trials.gov registration (NCT03544710)

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