Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The University of Western Australia | OTHER |
| University of Melbourne | OTHER |
| Malaria in Pregnancy Consortium | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Plasmodium falciparum parasitaemia in pregnancy is associated with maternal anaemia, low birth-weight and increased perinatal mortality. Whilst continuous prophylaxis is difficult to implement, intermittent presumptive treatment in pregnancy (IPTp) has proved to be practical and effective. In PNG, pregnant women currently receive IPTp using sulfadoxine-pyrimethamine, however, this therapy has the potential to be compromised by parasite resistance.
The aim of the present trial is to assess the safety, tolerability, pharmacokinetics and efficacy of azithromycin (AZI) plus piperaquine (PQ) given as IPTp to pregnant Papua New Guinea women. The study will comprise of two sub-studies:
(i) A safety, tolerability and pharmacokinetic study of AZI-PQ in pregnancy. (ii) A safety, tolerability and preliminary efficacy study of AZI-PQ in pregnancy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efficacy Study: Azithromycin plus piperaquine | Experimental | At baseline, participants receive three daily doses (0, 24 and 48 hours) of i) 1 g azithromycin as 2 x film-coated 500 mg tablets ii) 960 mg piperaquine tetraphosphate tablets as 3 x 320 mg tablets |
|
| Efficacy Study Control: National Standard Treatment | Active Comparator | At baseline, participants receive a single dose of sulfadoxine-pyrimethamine comprising 1,500 mg of sulfadoxine and 75 mg pyrimethamine in tablet form |
|
| Pharmacokinetic Study: Azithromycin plus piperaquine | Experimental | At baseline, participants receive three daily doses (0, 24 and 48 hours) of i) 1 g azithromycin as 2 x film-coated 500 mg tablets ii) 960 mg piperaquine tetraphosphate tablets as 3 x 320 mg tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin plus piperaquine phosphate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of azithromycin plus piperaquine for the prevention of malaria during pregnancy | The efficacy of azithromycin plus piperaquine for the prevention of malaria infection during pregnancy will be investigated in 120 women. Women will be randomized to receive either (i) 3 daily doses of AZI plus PQ, or, (ii) single dose sulfadoxine-pyrimethamine Participants will be actively followed for a period of 42 days (1, 2, 3, 4, 7, 14, 21, 28 and 42 days after treatment). At each follow-up time point the participant will have a clinical examination, fundal height measurement and assessment of foetal lie, perform a symptoms questionnaire, blood film for malaria and other scheduled safety tests (eg. Hb, glucose, ultrasound). A single blood sample for pharmacokinetic analysis will be collected at Day 4. At delivery all participants and their babies will be assessed, including blood sample for Hb, glucose, blood spot for PCR, cord blood and maternal blood. Breast milk samples will be collected for 2 weeks (Day 1, 2, 3, 4, 7, 14) after the establishment of lactation. | 42 days intensive follow-up, final end-point at 2 weeks post delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - distribution, terminal elimination and absorption half-life(t1/2) of azithromycin and piperaquine | 42 days intensive follow-up, final end-point at 2 weeks post delivery | |
| Pharmacokinetics - area under the plasma concentration versus time curve (AUC) of azithromycin and piperaquine |
| Measure | Description | Time Frame |
|---|---|---|
| Change in maternal hemoglobin over 28 days | 28 days | |
| Change in maternal weight over 28 days | 28 days | |
| Infant birth weight |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothy ME Davis, BMedSc MBBS DPhil FRACP MRCP | Contact | (+618) 9431 3229 | tim.davis@uwa.edu.au | |
| Brioni R Moore, BSc, PhD | Contact | (+618) 6151 1172 | brioni.moore@uwa.edu.au |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papua New Guinea Institute of Medical Research | Recruiting | Madang | Madang Province | 511 | Papua New Guinea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sulfadoxine-pyrimethamine | Drug |
|
| 42 days intensive follow-up, final end-point at 2 weeks post delivery |
| Pharmacokinetics - peak plasma concentration (Cmax) of azithromycin and piperaquine | 42 days intensive follow-up, final end-point at 2 weeks post delivery |
| Pharmacokinetics - clearance (CL) of azithromycin and piperaquine | 42 days intensive follow-up, final end-point at 2 weeks post delivery |
| Pharmacokinetics - volume of distribution (Vd) of azithromycin and piperaquine | 42 days intensive follow-up, final end-point at 2 weeks post delivery |
| PCR adjusted 28 day cure | 28 days |
| PCR adjusted 42 day cure | 42 days |
| Number of participants with adverse events as a measure of safety and tolerability | 42 days intensive follow-up, final end-point at 2 weeks post delivery |
| Time of delivery |
| Maternal parasitaemia | Time of delivery |
| Placental parasitaemia | Time of delivery |
| Cord blood parasitaemia | Time of delivery |
| Maternal hemoglobin at delivery | Time of delivery |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017963 | Azithromycin |
| C034759 | piperaquine |
| C001205 | fanasil, pyrimethamine drug combination |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided