Adoke Yeka
ID: UNCST-2021-R004300
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An adaptive, randomized, active-controlled, open-label, sequential cohort,
multicenter study to evaluate the efficacy, safety, tolerability and
pharmacokinetics of intravenous cipargamin (KAE609) in adult and pediatric
participants with severe Plasmodium falciparum malaria (KARISMA –
KAE609’s Role In Severe Malaria)
REFNo: HS1980ES
Primary objective
To assess the efficacy of different doses of
intravenous cipargamin vs artesunate by evaluating the proportion of
participants with ? 90% reduction of parasitemia at 12 hours post
administration of the first dose.
Secondary Objectives
1. To assess the presence/absence of severe malaria related individual
signs over time
2. To evaluate parasite clearance dynamics and proportion of participants
with recrudescence and reinfection
3. To assess recovery of participants as measured by time (days and hours)
to discharge from hospital or recovery from prostration
4. To evaluate the safety and tolerability of IV cipargamin
5. To assess the risk of long term neurological sequelae for participants at
Day 29
6. The assess the risk of hemolysis (early and delayed) during the study
duration
7. To characterize the plasma pharmacokinetics of IV cipargamin
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Tororo, Masafu
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Uganda |
2023-08-18 9:05:14 |
2026-08-18 |
200 patients for AL treatment arm and 100 patients for the other treatment arms per site. At least two drugs will be studied per site |
The study population will consist of male and female participants, including
pediatric participants aged ? 6 months or older. Approximately 252
participants (60 participants of ? 12 years and 192 participants < 12 years)
will be randomized |
Novartis |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Henry Mugerwa
ID: UNCST-2019-R000420
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PLATINUM: A multi-part, multi-center PLATform study to assess the efficacy, safety, tolerability and pharmacokinetics of anti-malarial agents administered as monotherapy at multiple dose levels and/or combination therapy IN patients with Uncomplicated Plasmodium falciparum Malaria
REFNo: HS2748ES
Main Objectives:
1. Part A: To assess the parasite clearance time (PCT) of oral doses of an anti- malarial agent administered as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as combination therapy versus the standard of care (SoC) in patients with uncomplicated P. falciparum malaria
Secondary Objectives
1. Part A: To assess the effect on adjusted 28-day cure rate of an anti-malarial agent administered orally as monotherapy in patients with uncomplicated P. falciparum malaria
2. Part B: To assess the parasite clearance time (PCT) of oral combinations of anti-malarial agents versus SoC in patients with uncomplicated P. falciparum malaria
3. To characterize PK of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy [Part B] in patients with uncomplicated P. falciparum malaria
4. To assess the safety and tolerability of each anti-malarial agent administered orally as monotherapy [Part A] and/or as combination therapy versus SoC [Part B] in patients with uncomplicated P. falciparum malaria
|
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Uganda |
2023-08-10 13:49:44 |
2026-08-10 |
14 |
The study population will consist of male and female patients aged ≥18 years for Part A and aged ≥12 years for Part B. |
Novartis |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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Bernard Kikaire
ID:
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Effect of an interactive SMS system in improving the reporting of adverse drug reactions among people living with HIV in Tanzania and Uganda: a randomized controlled trial: The REMIND ADR TRIAL
REFNo: HS2922ES
To investigate the effectiveness of SMS reminders on improving ADR reporting compared to no SMS among people living with HIV in Tanzania and Kampala Uganda.
To describe the most commonly reported ADR profiles among people living with HIV in Tanzania and Uganda.
To determine the most common routes/ methods of reporting ADR used by PLHIV.
To explore the causal relationship between the commonly reported ADRs and ART.
To improve treatment options for participants who reported ADR.
To explore the technical feasibility and acceptability of the intervention in reporting ADR among PLHIV.
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Kampala, mulago
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Uganda |
2023-08-08 12:42:32 |
2026-08-08 |
114 |
Age between 18 and 65
confirmed and documented HIV infection
Being on ART treatment for less than one year
Able to read and understand SMS
Able to understand and willing to sign the informed consent document
Able to read and write a text message
Have a mobile phone
|
The study is funded by Eastern Africa Consortium for Clinical Research (EACCR3) which is a network of excellence under EDCTP |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Joseph Lutaakome
ID: UNCST-2020-R008323
|
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE)
REFNo: HS2703ES
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) is a master protocol being conducted in many countries around the world, and funded by the National Institutes of Health, USA. STRIVE will evaluate the safety and effectiveness of unlicensed and licensed treatments and different combinations of treatments, to improve the health outcomes of adults
hospitalised with acute respiratory infections, like COVID-19 or influenza.
|
Kampala, Kampala
Masaka, Masaka
Gulu, Gulu
Lira, Lira
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Uganda |
2023-08-08 12:39:21 |
2026-08-08 |
1,500 |
The participant population are non-pregnant or breast-feeding adults aged ≥ 18 years; with confirmed COVID-19 for <14 days, and requiring inpatient hospital acute medical care and with evidence of a COVID-19 lower respiratory tract infection. |
National Institutes of Health |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
|
Harriet Mayanja-Kizza
ID: UNCST-2021-R013074
|
A phase 2, partially-blinded, randomised trial assessing the
safety and efficacy of TBAJ876 or bedaquiline, in combination
with pretomanid and linezolid in adult participants with newly
diagnosed, drug-sensitive, smear-positive pulmonary
tuberculosis
REFNo: HS2928ES
The objectives of the trial are to evaluate the efficacy, safety, and tolerability of TBAJ876 (3 doses) or bedaquiline in combination with pretomanid and linezolid in adult participants with newly diagnosed, smear-positive pulmonary DS-TB in comparison to the SOC
|
Kampala, Mulago
Kampala, Lubowa
|
Uganda |
2023-08-07 15:20:08 |
2026-08-07 |
The trial is planned to randomise at least 60 participants per treatment arm, for a total of at least 300 participants randomised. |
Study population should have the following characteristics:
1. Signed written informed consent prior to undertaking any trial-related procedures.
2. Participants aged 18 to 65 years, inclusive.
3. Body weight (in light clothing and no shoes) ≥35 kg.
4. Sputum positive for tubercle bacilli (at least 1+ on the IUATLD/WHO scale on smear
microscopy) at the trial laboratory.
5. DS-TB participants defined as the following:
a. Sensitive to rifampicin and isoniazid by rapid sputum-based test (see trial
Mycobacteriology Laboratory Manual) AND
b. Either newly diagnosed for TB or have a history of being untreated for at least 3
years after cure from a previous episode of TB.
6. A chest x-ray during the screening period or within 14 days of screening which in the
opinion of the investigator is compatible with pulmonary TB.
7. Be of non-childbearing potential OR using effective methods of birth control as defined
below:
Non-childbearing Potential
a. Participant is not heterosexually active or practices sexual abstinence OR
b. Female participant or male participant’s female sexual partner: bilateral
oophorectomy, bilateral tubal ligation, and/or hysterectomy or has been postmenopausal with a history of no menses for at least 12 consecutive months
OR
c. Male participant or female participant’s male sexual partner: vasectomized or
has had a bilateral orchidectomy at least 3 months prior to screening
Effective method of birth control is defined as 1 of the following:
a. Double-barrier method which can include a combination of male condom,
diaphragm, cervical cap, or female condom.
Note: Female and male condom should not be used together.
b. Combination of a barrier method with hormone-based contraceptives or an intrauterine device.
Both male and female participants must be willing to continue practicing birth control
methods and not be planning to conceive throughout treatment and for 6 months after
the last dose of IMP.
References to male or female mean “assigned male or female at birth,” respectively.
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TB Alliance |
Medical and Health Sciences |
Clinical Trial |
Non-degree Award |
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