Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206584817951 Date of Approval: 10/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy and safety of Praziquantel for treatment of Plasmodium falciparum infection in asymptomatic Gabonese adults
Official scientific title Efficacy and safety of Praziquantel for treatment of Plasmodium falciparum infection in asymptomatic Gabonese adults
Brief summary describing the background and objectives of the trial Occasionally, specific antimicrobial agents demonstrate simultaneous activity against multiple microorganisms. This introduces the promising possibility of creating drug regimens to be potentially used for more than only one treatment indication. Furthermore, the value of such multi-disease drug regimens rises when designed for important infectious diseases that affect a similar target population; an aspect making such regimens appealing to be operationally implemented not only, but particular in low resource settings. Epidemiologic data indicate that malaria and urogenital schistosomiasis are two infectious diseases affecting largely overlapping target populations. Treatment of urogenital schistosomiasis is based on praziquantel [PZQ], which is the only available drug for this indication. Interestingly, preliminary studies demonstrated that PZQ also exerts a relevant activity against Plasmodium parasites in vitro and in patients with falciparum malaria. However, this effect has not yet been further investigated. In the CORMA-MAL study, existing preliminary evidence of PZQ antimalarial activity will be further investigated. CORMA-MAL is a placebo-controlled randomised trial to evaluate the in vivo efficacy, safety and tolerability of PZQ in monotherapy. Adult participants with asymptomatic Plasmodium falciparum infection will be randomly allocated to one of two study arms with 22 participants in a placebo arm and 22 in an intervention arm with PZQ 40mg/kg once-daily dosing for 3 days. Aim: To assess efficacy of PZQ in asymptomatic participants with Plasmodium falciparum infection Primary objective: To assess the proportion of participants with microscopically-determined parasite clearance on D7 after administration of PZQ compared with placebo
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CORMAMAL
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 17/03/2022
Actual trial start date 17/03/2022
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date 24/02/2023
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants) 44
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo placebo will be dosed once-daily for 3 days. The same number of placebo tablets shall be administered as PZQ tablets would be necessary for a participant of a given body weight. once-daily dose for 3 days Placebo administered as once-daily dose for 3 consecutive days 22 Placebo
Experimental Group Praziquantel Praziquantel 40mg/kg/day once-daily dose for 3 consecutive days Oral treatment with Praziquantel 40mg/kg/day administered as once-daily dose for 3 consecutive days 22
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Subject male or female with age ≥ 18 years • Plasmodium parasitaemia with 200 to 5000 parasites/µL • Asymptomatic malaria defined by: presence of Plasmodium parasites with absence of fever (axillary temperature ≤ 37.5 ° C or oral / tympanic temperature ≤ 38 ° C, or absence of history of fever in recent 24 hours and the week before inclusion). • Signed and written informed consent • Willingness not to take drugs or substances which could have an impact on praziquantel blood levels • Women only: Must agree to practice continuous contraception for the duration of the study. Those methods include: combined (estrogen and progestogen containing) hormonal contraception, associated with inhibition of ovulation, oral, intravaginal or transdermal progestogen-only hormonal contraception associated with inhibition of ovulation, oral, injectable, implantable intrauterine device (IUD), intrauterine hormonereleasingsystem (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence and use of condoms. • Signs and symptoms of complicated malaria / severe malaria • Taking an experimental drug in the last 4 weeks. • Any antimalarial treatment in the last 4 weeks • Is using and intends to continuing using a medication known to cause drug reactions with artemether/lumefantrine (e.g. cimetidine, metoclopramide, antacids, kaolin, terfenadine etc.) • Use of systemic antibiotics with known antimalarial activity within 30 days of study enrolment (e.g. trimethoprim-sulfamethoxazole, doxycycline, tetracycline, clindamycin, erythromycin, fluoroquinolones, or azithromycin). • Use of praziquantel within 30 days of study enrolment. • Previous (within the last 10 years) participation in a malaria vaccine study • Moderate to severe anemia (Hemoglobin level < 8 g/dL) • Known history of hepatic disease or liver damage • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection • Use of immunoglobulins or blood products within 3 months prior to enrolment • Contraindications or known allergy to praziquantel or the first-line anti-malarial medication artemether/lumefantrine, or known or suspected allergy or intolerance to any other ingredient of the drug products (IMP/Non-IMP) • Severe malnutrition (Body Mass Index (BMI) < 16.0) • Pregnancy, lactation or intention to become pregnant during the study • Known history of sickle cell anaemia, sickle cell trait, thalassemia or thalassemia trait • Participants unable to be closely followed for social, geographic or psychological reasons Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 69 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/03/2022 Comite d Ethique Institutionnel CEI
Ethics Committee Address
Street address City Postal code Country
Hopital Albert Schweitzer Lambarene B.P.242 Gabon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assessment of the proportion of participants with microscopically-determined parasite clearance on D7 after administration of PZQ compared with placebo D7
Secondary Outcome Assessment of the proportion of participants with ≥90% parasitemia reduction on D7 compared with baseline between PZQ and placebo study arms D3,D7
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherches Medicales de Lambarene CERMEL Hopital Albert Schweitzer Lambarene B.P 242 Gabon
FUNDING SOURCES
Name of source Street address City Postal code Country
DZIF Inhoffenstr 7 Braunschweig PLZ:38124 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Bernhard Nocht Institut for Tropical Medicine Bernhard-Nocht-Str 74 Hamburg PLZ: 2035 Germany Institute of tropical Medicine
COLLABORATORS
Name Street address City Postal code Country
Centre de Recherches Medicales de Lambarene CERMEL Hopital Albert schweitzer Lambarene B.P 242 Gabon
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Johannes Mischlinger mischlinger@bnitm.de +494042818480 Bernhard-Nocht-str 74
City Postal code Country Position/Affiliation
Hamburg 20359 Germany BNITM
Role Name Email Phone Street address
Principal Investigator Ghyslain Mombo Ngoma ghyslain.mombongoma@gmail.com +24166072578 Hopital Albert Shceitzer
City Postal code Country Position/Affiliation
Lambarene B.P 242 Gabon Head of clincal laboratory Cermel
Role Name Email Phone Street address
Public Enquiries Lidwine Badjina lidwine.badjina@bnitm.de +494042818705 Bernhard-Nocht-str 74
City Postal code Country Position/Affiliation
Hamburg 20359 Gabon BNITM
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in malaria drug development. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Clinical Study Report,Study Protocol Data requests can be submitted starting 60 days after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA). For more information or to submit a request to the sponsor.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information